U.S. patent number 8,386,070 [Application Number 12/628,884] was granted by the patent office on 2013-02-26 for automated pharmacy admixture system.
This patent grant is currently assigned to Intelligent Hospital Systems, Ltd. The grantee listed for this patent is Dustin Deck, Thom Doherty, Walter W. Eliuk, Lance R. Mlodzinski, Alex H. Reinhardt, Ronald H. Rob. Invention is credited to Dustin Deck, Thom Doherty, Walter W. Eliuk, Lance R. Mlodzinski, Alex H. Reinhardt, Ronald H. Rob.
United States Patent |
8,386,070 |
Eliuk , et al. |
February 26, 2013 |
Automated pharmacy admixture system
Abstract
In a preferred implementation, an automated pharmacy admixture
system (APAS) prepares intermediary IV bags as drug sources for
creating highly diluted patient doses in syringes. During the
compounding process the APAS may align needles with a vial seal
opening so as to ensure repeated entry through the same vial
puncture site via precise control of needle position, needle bevel
orientation, and needle entry speed. These techniques can in
certain implementations substantially improve bung pressure sealing
and reduced particulate generation. The APAS optionally creates
drug order queues for incoming drug orders wherein the orders can
be sorted by priority, drug type or patient location. A phantom
queue can be combined with the incoming drug order queues to
include frequently used medicaments to minimize operator loading of
the APAS.
Inventors: |
Eliuk; Walter W. (Winnipeg,
CA), Rob; Ronald H. (Dugald, CA),
Mlodzinski; Lance R. (Winnipeg, CA), Reinhardt; Alex
H. (St. Andrews, CA), Doherty; Thom (Winipeg,
CA), Deck; Dustin (St. Andrews, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Eliuk; Walter W.
Rob; Ronald H.
Mlodzinski; Lance R.
Reinhardt; Alex H.
Doherty; Thom
Deck; Dustin |
Winnipeg
Dugald
Winnipeg
St. Andrews
Winipeg
St. Andrews |
N/A
N/A
N/A
N/A
N/A
N/A |
CA
CA
CA
CA
CA
CA |
|
|
Assignee: |
Intelligent Hospital Systems,
Ltd (Winnipeg, CA)
|
Family
ID: |
42738342 |
Appl.
No.: |
12/628,884 |
Filed: |
December 1, 2009 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20100241270 A1 |
Sep 23, 2010 |
|
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
61161381 |
Mar 18, 2009 |
|
|
|
|
61254625 |
Oct 23, 2009 |
|
|
|
|
Current U.S.
Class: |
700/214; 141/1;
221/197; 141/130; 221/191; 700/231; 700/213; 141/114; 700/228 |
Current CPC
Class: |
A61J
1/20 (20130101); B01F 13/1072 (20130101); A61J
2200/10 (20130101); A61M 5/3286 (20130101); A61J
1/201 (20150501); A61J 1/2096 (20130101); A61J
1/10 (20130101); A61J 3/002 (20130101); A61M
5/3291 (20130101) |
Current International
Class: |
B65B
3/00 (20060101) |
Field of
Search: |
;700/213,214,228,231,90
;141/1,114,130 ;221/191,197,198 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1317262 |
|
Sep 1989 |
|
CA |
|
4314657 |
|
Nov 1994 |
|
DE |
|
1316152 |
|
Dec 2000 |
|
IT |
|
WO 90/09776 |
|
Sep 1990 |
|
WO |
|
WO 94/04415 |
|
Mar 1994 |
|
WO |
|
WO 95/15142 |
|
Jun 1995 |
|
WO |
|
WO 97/43915 |
|
Nov 1997 |
|
WO |
|
WO 99/29412 |
|
Jun 1999 |
|
WO |
|
WO 99/29415 |
|
Jun 1999 |
|
WO |
|
WO 99/29467 |
|
Jun 1999 |
|
WO |
|
WO 00/16213 |
|
Mar 2000 |
|
WO |
|
WO 2006/069361 |
|
Jun 2006 |
|
WO |
|
WO 2006/124211 |
|
Nov 2006 |
|
WO |
|
WO 2008/058280 |
|
May 2008 |
|
WO |
|
WO 2008/101353 |
|
Aug 2008 |
|
WO |
|
WO 2009/033283 |
|
Mar 2009 |
|
WO |
|
WO 2009/062316 |
|
May 2009 |
|
WO |
|
Other References
"Aseptic Technique Process and End-product Evaluation," Department
of Pharmacy Policy, 1994, University of Kentucky Hospital, Chandler
Medical Center, 4 pages. cited by applicant .
"Basic Definitions and Data for Electron Beam Sterilization," by
Dr. Alex Wekhof, SteriBeam Systems, GmbH, 2005. cited by applicant
.
"BD Helping all people live health lives Prefilled. Proven.
Preferred.," BD Product Literature, BD, 2000. cited by applicant
.
"Disinfection with Flash Lamps," by A. Wekhof, PDA Journal of
Pharmaceutical Science & Technology, vol. 54, No. 3, May/Jun.
2000. cited by applicant .
"Does the Engineering of the PureBright Sterilisation System Match
the Pulsed Light Sterilisation Process?," by Dr. Alex Wekhof,
Advanced Ultra-Fast Sterilisaton from SteriBeam Systems GmbH, Kehl,
Germany, http://www.steribeam.com/articles/WTPP-Rep/html, 2001.
cited by applicant .
Industrial Automated Pulsed UV Modules, Advanced Pulsed UV and
Corona Systems from SteriBeam GmbH, Kehl, Germany,
http://www.steribeam.com/f-scale.puv, Printed Jan. 25, 2008. cited
by applicant .
"Pulsed UV Disintegration (PUVD): a new sterilization mechanism for
packaging and broad medical-hospital applications," by Dr. Alex
Wekhof, Dipl-Phys. Franz-Josef Trompeter, Dipl.-Ing. Oliver
Franken, The First International Conference on Ultraviolet
Technologies, Jun. 14-16, 2001, Washington, D.C. cited by applicant
.
Robotic system for i.v. antineoplastic drug preparation:
Description and preliminary evaluation under simulated conditions
by Dennis D. Cote and Mark G. Torchia, American Journal of Hospital
Pharmacy, vol. 46, Nov. 1989. cited by applicant .
"Two UV-flashlamps R&D/Labor Automated System," Advanced Pulsed
UV and Corona Systems From SteriBeam GmbH, Kehl, Germany,
http://www.steribeam.com/xe-labor-wt.html, printed Mar. 24, 2006.
cited by applicant .
Biomedical Technology Consulting, "05BTC--Cytocare: Automatic
system for the preparation of cytostatic drugs," pp. 1-22 with
translation; downloaded from Internet site www.tecnomedical.com on
Aug. 14, 2006. cited by applicant .
"Welcome to the Future. The Robotic IV Admixture System: The
established wave of the future with real bottom line savings."
Robotic IV Admixture System; Canada, 1992. cited by applicant .
"Dose Systems." Pharmaceutical Journal; pp. 757, vol. 254, No.
6843; Jun. 3, 1995. cited by applicant .
International Search Report and Written Opinion, PCT/CA2008/001613
dated Sep. 12, 2008, 10 pages. cited by applicant .
International Search Report and Written Opinion, PCT/US2006/15731
dated Jul. 29, 2008, 10 pages. cited by applicant .
International Search Report and Written Opinion, PCT/US2007/84332
dated Jul. 1, 2008, 11 pages. cited by applicant .
International Search Report and Written Opinion, PCT/US2005/046978
dated Aug. 2, 2006, 16 pages. cited by applicant .
International Search Report and Written Opinion, PCT/CA2008/002027
dated Feb. 25, 2009, 12 pages. cited by applicant .
Definition of "cannula", Webster's Third New International
Dictionary, Unabridged. Copyright 1993 Merriam-Webster,
Incorporated. cited by applicant .
Kohler, et al. "Standardizing the expression and nomenclature of
cancer treatment regiments,", Am J Health-Svst Pharm: 1998; 55:
137-144. cited by applicant .
Office Action in Re Exam Control No. 95/000,333; mailed Mar. 7,
2008; 36 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,333; mailed May 5,
2009; 43 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,334; mailed Feb. 27,
2008; 17 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,335; mailed Mar. 7,
2008; 16 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,336; mailed Mar. 11,
2008; 36 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,336; mailed Oct. 15,
2008; 21 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,340; mailed Mar. 21,
2008; 41 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,340; mailed Mar. 30,
2009; 69 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,342; mailed Mar. 11,
2008; 18 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,342; mailed Oct. 15,
2008; 28 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,345; mailed Apr. 23,
2008; 32 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,345; mailed Mar. 30,
2009; 67 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,333; filed
Jun. 12, 2008, 11 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,333; filed
Jun. 7, 2008, 37 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,333; filed
Jun. 16, 2009, 16 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,335; filed
Jun. 7, 2008, 33 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,336; filed
Nov. 14, 2008, 35 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,336; filed
Jun. 12, 2008, 13 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,336; filed
Jun. 7, 2008, 43 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,340; filed
Jun. 12, 2008, 10 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,340; filed
May 20, 2008, 33 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,342; filed
Jun. 7, 2008,32 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,342; filed
Nov. 13, 2008, 14 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,345; filed
Jun. 23, 2008, 32 pages. cited by applicant .
Patent Owner's Response in Re Exam Control No. 95/000,345; filed
Apr. 29, 2009, 8 pages. cited by applicant .
Request for InterPartes Reexamination in Reexam Control No.
95/000,333; filed Jan. 11, 2008; 26 pages. cited by applicant .
Request for InterPartes Reexamination in Reexam Control No.
95/000,334; filed Jan. 11, 2008; 54 pages. cited by applicant .
Request for InterPartes Reexamination in Reexam Control No.
95/000,335; filed Jan. 11, 2008; 73 pages. cited by applicant .
Request for InterPartes Reexamination in Reexam Control No.
95/000,336; filed Jan. 11, 2008; 97 pages. cited by applicant .
Request for InterPartes Reexamination in Reexam Control No.
95/000,340; filed Jan. 30, 2008; 33 pages. cited by applicant .
Request for InterPartes Reexamination in Reexam Control No.
95/000,342; filed Feb. 1, 2008; 27 pages. cited by applicant .
Request for InterPartes Reexamination in Reexam Control No.
95/000,345; filed Feb. 11, 2008; 32 pages. cited by applicant .
Third Party Comments on Patent Owner Response in Reexam Control No.
95/000,333; filed Jul. 7, 2008; 29 pages. cited by applicant .
Third Party Comments on Patent Owner Response in Reexam Control No.
95/000,335; filed Jul. 7, 2008; 18 pages. cited by applicant .
Third Party Comments on Patent Owner Response in Reexam Control No.
95/000,336; filed Dec. 15, 2008; 7 pages. cited by applicant .
Third Party Comments on Patent Owner Response in Reexam Control No.
95/000,336; filed Jul. 7, 2008; 15 pages. cited by applicant .
Third Party Comments on Patent Owner Response in Reexam Control No.
95/000,340; filed Jun. 19, 2008; 19 pages. cited by applicant .
Third Party Comments on Patent Owner Response in Reexam Control No.
95/000,342; filed Dec. 15, 2008; 7 pages. cited by applicant .
Third Party Comments on Patent Owner Response in Reexam Control No.
95/000,342; filed Jul. 7, 2008; 28 pages. cited by applicant .
Third Party Comments on Patent Owner Response in Reexam Control No.
95/000,345; filed Jul. 23, 2008; 16 pages. cited by applicant .
Third Party Comments on Patent Owner Response in Reexam Control No.
95/000,333; filed Jul. 16, 2009; 11 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,345; mailed Jul. 2,
2009 73 pages. cited by applicant .
Office Action in Re Exam Control No. 95/000,340; mailed Jul. 20,
2009, 8 pages. cited by applicant .
EPO Extended European Search Report for EP Application No.
06751430.7 (PCT/US2006/015731), mailed Sep. 14, 2009, 7 pages.
cited by applicant .
Office Action in Re Exam Control No. 95/000,335; mailed Oct. 1,
2009 27 pages. cited by applicant .
Re Exam Notification re Brief, Control No. 95/000,334; mailed Sep.
29, 2009 7 pages. cited by applicant .
Re Exam Right of Appeal Notice, Control No. 95/000,333; mailed Dec.
2, 2009, 30 pages. cited by applicant .
International Preliminary Report on Patentabililty,
PCT/CA2008/000348, dated Sep. 3, 2009, 10 pages. cited by applicant
.
International Search Report and Written Opinion, PCT/CA2008/000348
dated Jun. 3, 2008, 10 pages. cited by applicant .
Office Action in U.S. Appl. No. 11/316,795 notification date Dec.
29, 2008, 16 pages. cited by applicant .
Office Action in U.S. Appl. No. 11/389,995 notification date Apr.
28, 2009, 8 pages. cited by applicant .
Patent Owner's Entry in Reexam Control No. 95/000,333; filed Jan.
22, 2010; 32 pages. cited by applicant .
Interview Summary in U.S. Appl. No. 11/316,795 notification date
Feb. 24, 2009; 4 pages. cited by applicant .
Reply to office action in U.S. Appl. No. 11/316,795 notification
date Mar. 27, 2009; 14 pages. cited by applicant .
Notice of Allowance in U.S. Appl. No. 11/316,795 mailing date Jun.
22, 2009; 6 pages. cited by applicant .
Interview Summary in U.S. Appl. No. 11/389,995 notification date
Jun. 17, 2009; 4 pages. cited by applicant .
Reply to office action in U.S. Appl. No. 11/389,995 notification
date Sep. 15, 2009; 14 pages. cited by applicant .
Express Withdrawal of Appeal in Reexam control No. 95000334; filed
Oct. 29, 2009; 4 pages. cited by applicant .
Patent Owner Petition in Reexam control No. 95/000334; filed Nov.
10, 2009; 8 pages. cited by applicant .
Reply to Office Action in European Application serial No.
05855521.0, filed Jan. 8, 2010, pp. 15. cited by applicant .
PCT/CA2010/000073 Written Opinion of International Searching
Authority issued Mar. 11, 2010, 3 pages. cited by
applicant.
|
Primary Examiner: Mackey; Patrick
Attorney, Agent or Firm: Oblon, Spivak, McClelland, Maier
& Neustadt, L.L.P.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims priority under 35 U.S.C. .sctn.119(e) to
U.S. Provisional Patent Application Ser. No. 61/254,625, entitled
"Method And Apparatus For Intermediate IV Bag Handling", and filed
by Eliuk et al. on Oct. 23, 2009; and to U.S. Provisional Patent
Application Ser. No. 61/161,381, entitled "Vial Seal Puncturing,"
and filed by Mlodzinski et al. on Mar. 18, 2009, the entire
disclosures of which are incorporated herein by reference.
This application also claims the benefit of the currently pending
U.S. patent application Ser. No. 12/271,828, entitled "Method And
Apparatus For Automated Fluid Transfer Operations," and filed by
Eliuk et al. on Nov. 14, 2008; U.S. patent application Ser. No.
12/209,097, entitled "Gripper Device," and filed by Eliuk et al. on
Sep. 11, 2008; U.S. patent application Ser. No. 12/035,850,
entitled "Ultraviolet Sanitization in Pharmacy Environments," and
filed by Reinhardt et al. on Feb. 22, 2008; U.S. patent application
Ser. No. 11/937,846, entitled "Control of Fluid Transfer
Operations," and filed by Doherty et al. on Nov. 9, 2007; and U.S.
patent application Ser. No. 11/389,995, entitled "Automated
Pharmacy Admixture System," and filed by Eliuk et al. on Mar. 27,
2006, the entire disclosures of which are incorporated by
reference.
This application also incorporates herein the entire disclosure by
reference: U.S. Pat. No. 7,610,115, entitled "Automated Pharmacy
Admixture System (APAS)," and filed by Rob et al. on Dec. 22,
2005.
The entire disclosure of each of the following documents is
incorporated by reference herein: U.S. Provisional Patent
Application Ser. No. 60/971,815, entitled "Gripper Device," and
filed by Eliuk et al. on Sep. 12, 2007; U.S. Provisional Patent
Application Ser. No. 60/891,433, entitled "Ultraviolet Disinfection
in Pharmacy Environments," and filed by Mlodzinski et al. on Feb.
23, 2007; U.S. Provisional Patent Application Ser. No. 60/865,105,
entitled "Control of Needles for Fluid Transfer," and filed by
Doherty et al. on Nov. 9, 2006; U.S. Provisional Application Ser.
No. 60/681,405, entitled "Device and Method for Cleaning and
Needle/Cap Removal in Automated Pharmacy Admixture System," and
filed by Rob et al. on May 16, 2005; U.S. Provisional Application
Ser. No. 60/638,776, entitled "Automated Pharmacy Admixture
System," and filed on Dec. 22, 2004; U.S. patent application Ser.
No. 12/271,828, entitled "Method And Apparatus For Automated Fluid
Transfer Operations," and filed by Eliuk et al. on Nov. 14, 2008;
U.S. patent application Ser. No. 12/209,097, entitled "Gripper
Device," and filed by Eliuk et al. on Sep. 11, 2008; U.S. patent
application Ser. No. 12/035,850, entitled "Ultraviolet Sanitization
in Pharmacy Environments," and filed by Reinhardt et al. on Feb.
22, 2008; U.S. patent application Ser. No. 11/937,846, entitled
"Control of Fluid Transfer Operations," and filed by Doherty et al.
on Nov. 9, 2007; U.S. patent application Ser. No. 11/389,995,
entitled "Automated Pharmacy Admixture System," and filed by Eliuk
et al. on Mar. 27, 2006; and U.S. patent application Ser. No.
11/316,795, entitled "Automated Pharmacy Admixture System," and
filed by Rob et al. on Dec. 22, 2005.
Claims
We claim:
1. A robotic automated pharmaceutical processing system comprising:
a processor-based interface configured to receive requests to
prepare one or more pharmaceutical prescriptions; and a controller
coupled to the interface and configured to operate an automated
prescription preparation device in response to the received
requests, the automated prescription preparation device comprising:
an inventory chamber comprising a housing to store within the
inventory chamber a plurality of inventory items to be used in the
preparation of one or more pharmaceutical prescriptions; an
exterior access portal formed in a first side wall of the housing
of the inventory chamber, wherein the exterior access portal is
operable between a closed position and an open position to provide
an operator access for loading and unloading inventory items in the
inventory chamber; a compounding chamber access portal in a second
side of the inventory chamber; a rotatable inventory carousel
disposed in the inventory chamber to receive the plurality of
inventory items, wherein the carousel is rotatable about a vertical
axis and comprises a first plurality of locations each adapted to
receive an IV bag, a second plurality of locations each adapted to
receive a vial that contains a drug, and a third plurality of
locations each adapted to receive a syringe configured with a
plunger slidably disposed within a first end of a barrel and a
needle coupled to a second opposite end of the barrel, and wherein
the carousel is configured to bring a selected one of the locations
in proximity to the compounding chamber access portal to present a
selected inventory item being stored at the selected location to
the compounding chamber access portal; a compounding chamber
adjacent to the inventory chamber and communicating with the
inventory chamber through the compounding chamber access portal in
the second side, the second side being disposed between the
compounding chamber and the inventory chamber; a multi-axis
multi-linkage robot disposed within the compounding chamber and
configured to grasp an inventory item being presented from the
carousel in the inventory chamber to the compounding chamber access
portal, convey the grasped inventory item to a first process
location, release the inventory item for processing at the first
process location, and subsequently convey the processed inventory
item to a second process location in the compounding chamber; a
syringe manipulator station configured to hold a syringe with a
needle directed in a generally upward orientation for drawing fluid
through the needle from a vial into the held syringe; a mixing
station configured to impart a motion to the vial to mix the
contents of the vial before the drawing of fluid from the vial; an
air handling system arranged to provide air flow through the
compounding chamber; a waste container area disposed in proximity
to the compounding chamber to receive inventory items that have
been processed in the compounding chamber; and wherein the
controller is adapted to cause articulation of the stations to
create an intermediary IV bag with a reconstituted drug at a
predetermined intermediate concentration, draw a dose of
intermediate concentration from the intermediary IV bag, and
further dilute the drawn dose to prepare a final dose at a
predetermined final dilution.
2. The system of claim 1, further comprising an aperture that
couples the compounding chamber to the waste container area,
wherein the air handling system is arranged to cause at least a
portion of the provided air flow to flow from an interior region of
the compounding chamber through the aperture generally toward a
waste container disposed in the waste container area.
3. The system of claim 1, wherein the air handling system is
further arranged to produce a substantially uniform airflow from a
ceiling of the compounding chamber toward a floor of the
compounding chamber.
4. The system of claim 1, wherein the air handling system is
further arranged to reduce air pressure inside the compounding
chamber to a level substantially below an ambient air pressure
proximate and exterior to the compounding chamber.
5. The system of claim 1, wherein the controller is adapted to
articulate one or more stations to determine the weight of an empty
IV bag.
6. The system of claim 5, wherein the controller is adapted to
determine the amount of diluent to remove to accommodate addition
of a predetermined amount of medicament to produce a needed
concentration level.
7. The system of claim 1, further comprising a vial seal puncturing
controller to position successive needles for entry into the same
vial puncture site.
8. The system of claim 7, wherein the vial seal puncturing
controller determines based at least in part on needle type the
needle engagement speed and disengagement speed to minimize leakage
and coring.
9. The system of claim 7, wherein the vial seal puncturing
controller modifies needle to vial engagement angles to enhance
bung puncture performance.
10. The system of claim 7, wherein the vial seal puncturing
controller modifies canting of the vial relative to needle bevel to
enhance bung puncture performance.
11. The system of claim 7, wherein a needle used to puncture the
vial is a pencil point needle that includes side ports.
12. The system of claim 7, wherein the vial seal puncturing
controller adjusts needle penetration to maximize the amount of
diluent that can be withdrawn from the vial.
13. The system of claim 1, wherein the controller manages batch
mode production queues at least in part by assigning priority of
drug orders in the queues.
14. The system of claim 13, wherein the controller executes
software polling via FTP and selectively interrupts batch mode
processing.
15. The system of claim 13, wherein the controller determines the
queue in which a drug order belongs by priority sorting, drug type
sorting, or location sorting.
16. The system of claim 13, wherein the controller combines a
phantom queue for future processing with an existing first group of
drug orders for current processing, resulting in a third group of
drug orders for processing and entry into the system.
17. The system of claim 1, wherein the controller detects and
recovers from errors by recovery of unused drugs, diluent and
containers and re-queuing drug orders.
18. The system of claim 1, wherein the controller acquires through
training or programming an actual amount of accessible fluid in a
specific container, wherein the actual amount of fluid in a
container is more than or less than the nominal amount of fluid in
the container.
19. The system of claim 1, comprising separate waste containers for
specific types of medical waste comprising sharps, glass, plastic,
and cytotoxic, wherein the system sorts the types of medical waste
into the various waste containers and wherein each waste container
has associated level sensors.
20. The system of claim 1, further comprising sensors on output
chutes to detect whether a completed product is output from the
system and wherein the controller interrupts processing at least in
selected circumstances wherein the sensor does not indicate the
output of a completed product.
21. The system of claim 1, wherein the controller minimizes cross
contamination by controlling gripper finger force, orientation of
gripped syringe to minimize affect of acceleration forces, or use
of slurp function to draw fluid out of needle and into luer lock of
syringe.
22. The system of claim 1, wherein the system is configured to
enhance the release of labeled vials from gripper fingers by
abrasion of moving grippers along axis of vial after partial
release of gripper fingers.
23. The system of claim 1, further comprising a kit to convert the
system to use a specific type of IV bag, wherein the kit includes a
disposable clip for attachment to an IV bag.
24. The system of claim 1, further comprising a syringe printer
platen adapted to register a label, the platen having a compliant
area for improved adhesion of the label to a syringe.
25. The system of claim 1, wherein the controller includes a
training interface to teach the robot interface relationships
including locations of system stations or subsystems.
26. The system of claim 25, wherein the robot retains a teaching
tool used during training operations, wherein the tool is
optionally an optical transducer.
Description
BACKGROUND
Many medications can be delivered to a patient from an intravenous
(IV) bag into which a quantity of a medication is introduced.
Sometimes, the medication may be an admixture with a diluent. In
some implementations, the IV bag contains the medication and
diluent. In some implementations, the IV bag may also contain a
carrier or other material to be infused into the patient
simultaneously with the medication. Medication can also be
delivered to a patient using a syringe.
Additionally, medication can be supplied in dry (e.g., powder) form
in a medication container such as a vial. A diluent liquid in a
separate or diluent container or vial may be supplied for
reconstituting with the medication. The resulting medication may
then be delivered to a patient according to the prescription.
One function of the pharmacist can be to prepare a dispensing
container, such as an IV bag or a syringe, which contains a proper
amount of diluent and medication according to the prescription for
that patient. Some prescriptions (e.g., insulin) may be prepared to
suit a large number of certain types of patients (e.g., diabetics).
In some implementations, a number of similar IV bags containing
similar medication can be prepared in a batch, although volumes of
each dose may vary. Other prescriptions, such as those involving
chemotherapy drugs, may call for very accurate and careful control
of diluent and medication to satisfy a prescription that is
tailored to the needs of an individual patient.
The preparation of a prescription in a syringe or an IV bag may
involve, for example, transferring fluids, such as medication or
diluent, among vials, syringes, and/or IV bags. IV bags can be
flexible, and may readily change shape as the volume of fluid they
contain changes. IV bags, vials, and syringes can be commercially
available in a range of sizes, shapes, and designs.
SUMMARY OF SELECTED IMPLEMENTATIONS
In a preferred implementation, an automated pharmacy admixture
system (APAS) prepares intermediary IV bags as drug sources for
creating highly diluted patient doses in syringes. During the
compounding process the APAS may align needles with a vial seal
opening so as to ensure repeated entry through the same vial
puncture site via precise control of needle position, needle bevel
orientation, and needle entry speed. These techniques can in
certain implementations substantially improve bung pressure sealing
and reduced particulate generation. The APAS optionally creates
drug order queues for incoming drug orders wherein the orders can
be sorted by priority, drug type or patient location. A phantom
queue can be combined with the incoming drug order queues to
include frequently used medicaments to minimize operator loading of
the APAS. The APAS can include an automated error recovery protocol
that recovers from faults encountered during medicament preparation
by reusing or discarding containers and doses, dependent on the
error encountered, and by requeuing the medicament order for
subsequent preparation. The APAS optionally sorts medical waste for
disposal from the system into a plurality of medical waste bins for
vials, syringes and unused liquids. In selected implementations,
the APAS can include a plurality of output chutes that include one
or more sensors to determine if the prepared dose has been
successfully outputted from the APAS. The APAS robot may be
configured to translate a syringe between substations in the APAS
in such a way as to avoid dripping the contents of the syringe on
any surfaces passed over during the movement in order to avoid
cross-contamination. The robot may also be configured to follow
specialized vial release protocols to counteract unintended
adhesive or abrasive contacts with the labels. The APAS can be
adapted to handle a plurality of different IV bag configurations
with adapted kits that include clips and attachments placed on the
IV bag to facilitate handling by the APAS gripper member. A printer
platen for a label station in the APAS can include a compliant area
to provide enhanced initial contact of a printed label with a
syringe. A teaching system is also optionally included in the APAS
to enable manual or autonomous teaching of interfaces in the APAS
to the robot.
DESCRIPTION OF DRAWINGS
FIG. 1 shows an illustrative Automated Pharmacy Admixture System
(APAS).
FIG. 2 shows a top cut-away view of the APAS of FIG. 1.
FIG. 3 shows an example table for minimum and maximum fill sizes
for an intermediary bag.
FIG. 4 shows an example vial parking.
FIG. 5 shows an example syringe manipulation device that includes a
liquid waste drain tube.
FIG. 6 shows an example liquid waste container.
FIG. 7 shows an example IV bag parking.
FIG. 8 shows an example adjusted volume weight verification
interpolation table.
FIG. 9 is an illustration of an example of a 18 gauge blunt fill
needle.
FIG. 10 is an illustration of a vial and a needle with a co-aligned
axis.
FIG. 11 is an illustration of a vial and a needle with the vial
axis canted relative to the needle axis.
FIG. 12 is an illustration of a vial and a needle with the needle
axis canted relative to the vial axis.
FIG. 13 is an illustration of an example pencil point needle
inserted into a vial bung of a top of a vial.
FIG. 14 is an illustration of an example narrow fluid channel on
the inside of a stopper.
FIG. 15 is an illustration of an example of a marginal needle
height.
FIG. 16 is an illustration of an example misalignment of a needle
with a previous puncture hole.
FIG. 17 is an illustration of an example needle with a long
point.
FIG. 18 is an illustration of an example needle with a short
point.
FIGS. 19A-19B show a needle puncture into a stopper on a vial prior
to needle entry into the vial.
FIGS. 20A-20B show a needle puncture into a stopper on a vial after
needle entry into the vial.
FIGS. 21A-21L are illustrations of example pencil point needles
that can be used in an APAS.
FIG. 22 is an illustration showing example pencil point needles
with side ports.
FIG. 23A is an illustration of an example vial bung (stopper) that
can be used in implementations and embodiments described
herein.
FIG. 23B is an illustration of an example vial with a bung and a
vial seal.
FIG. 23C is an illustration of an example vial with a bung sealed
to a vial with a vial seal.
FIG. 24 is an illustration of example syringe barrels.
FIGS. 25A-C are illustrations of example vial bungs.
FIG. 26 is a flow chart of an illustrative batch mode of operation
that can be used to fill drug orders provided to the APAS.
FIG. 27 is a flow chart of an on-demand mode of operation that may
be used to fill orders provided to the APAS.
FIG. 28 is a flow chart of an illustrative drug order processing
method for an APAS.
FIG. 29 is an illustrative flow chart showing example operations
for preprocessing a queue of drug orders.
FIG. 30 is an illustrative flow chart showing example operations
for inventory management and predictions.
FIG. 31 is an illustrative flow chart showing example operations
for detecting and recovering from errors that may occur while
processing drug orders.
FIG. 32 is an illustrative flow chart showing example operations
for drawing a volume of fluid from a fluid source, such as a
reconstituted or non-reconstituted drug vial, diluent bag, and/or
an intermediary bag.
FIGS. 33A and 33B show an illustrative waste bin area of an
APAS.
FIGS. 34A-34E show example views of a product output chute in an
APAS.
FIGS. 35A-35B show example views of a product output chute in the
course of releasing a product from an APAS.
FIG. 36 is an illustrative flow chart showing example operations
for detecting the presence of a product in a product output
chute.
FIGS. 37A-37B show an illustrative printer system for an APAS.
FIG. 38 is an illustration of a printer platen for labeling
syringes in a printer system.
FIG. 39 is an illustration of a printer platen for labeling
syringes in a printer system that shows a label.
FIG. 40 is an illustration of a printer platen for labeling
syringes in a printer system that shows a label and a syringe for
labeling.
FIG. 41 is an illustration of an example robot that includes a Z
pointer direct mounted teach tool.
FIG. 42 is an illustration of an example robot that includes a
straight pointer teach tool.
FIG. 43 is an illustration of an example robot that includes an
offset pointer teaching tool.
FIG. 44 is an illustration of an example robot that is a wielding
touch probe teach tool.
FIG. 45 is an illustration of an example touch probe teach tool in
the process of autonomous point teaching.
FIG. 46 is an example swimlane diagram showing a system for using
an APAS.
Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
In some implementations, an automated pharmacy admixture system
(APAS) includes sub-systems for automated fluid transfer operations
among medicinal containers such as syringes, vials, and IV bags. In
various examples, the systems and techniques are used in an APAS
during admixture or compounding and/or dispensing of drug doses.
Examples of an APAS are described, for example, with reference to
FIGS. 1 through 5 in U.S. Pat. No. 7,610,115, entitled "Automated
Pharmacy Admixture System (APAS)," and filed by Rob et al. on Dec.
22, 2005, and with reference to FIGS. 1 through 5 in U.S. patent
application Ser. No. 11/389,995, entitled "Automated Pharmacy
Admixture System," and filed by Eliuk et al. on Mar. 27, 2006, the
entire disclosure of each of which is incorporated herein by
reference.
In some implementations, an APAS includes a manipulator that
transports medical containers such as bags, vials, or syringes
about a substantially aseptic admixing chamber. In some examples,
the chamber includes a number of processing stations at which the
medical containers are processed to perform reconstitution for
prescription medication doses. In certain examples, such processing
stations include apparatus to substantially sanitize, disinfect,
and/or sterilize portions of the medical containers prior to
performing a fluid transfer operation.
In an example implementation, a gripper assembly is configured to
substantially universally grasp and retain syringes, IV bags, and
vials of varying shapes and sizes. In an illustrative embodiment, a
gripping device includes claws configured to grasp a plurality of
different types of IV bags, each type having a different fill port
configuration. Embodiments may include a controller adapted to
actuate a transport assembly to place a fill port of the bag, vial
or syringe into register with a filling port such as a cannula
located at a filling station, or be equipped with carousel
transport systems that are adapted to convey bags, vials, and
syringes to the admixture system and deliver constituted
medications in bags, vials or syringes to an egress area.
FIG. 1 shows an illustrative APAS 100 for use within a hospital
pharmacy environment. The APAS 100 automatically admixes the
contents of syringes and IV bags using automation technologies. For
example, embodiments of the APAS 100 can perform one or more
operations that might otherwise be performed by pharmacy staff
within a laminar airflow hood. The APAS 100 includes a robotic cell
that automates the compounding and dispensing of drug doses into IV
bags and/or syringes, such as those that may be prepared in
hospital pharmacies. The robotic cell can use a syringe-based fluid
transfer process, and can employ a robotic manipulator (e.g., a
multiple degree of freedom arm) for moving drug vials, syringes,
and IV bags through the cell as the medications are processed.
FIG. 2 shows an illustrative top cut-away view of the APAS of FIG.
1. The APAS 100 includes two chambers. An inventory chamber 202 is
used as an inventory loading area, which can be accessed by an
operator to load the APAS 100 through a loading door (not shown).
In some embodiments, the inventory chamber 202 provides a
substantially aseptic environment, which may be an ISO Class 5
environment that complies with clean room standards. A processing
chamber 204 includes the compounding area in which the admixture
and/or compounding processes may occur. In some embodiments, the
processing chamber 204 provides a substantially aseptic
environment, which may be an ISO Class 5 environment that complies
with clean room standards. Mounted on the exterior of the APAS 100
are two of the monitors 102, which may serve as input/output
devices.
The inventory chamber 202 includes two inventory rack carousels 210
and 212 and a temporary inventory rack 214. The temporary inventory
rack 214 can be used to locate in-process drug vials that contain
enough material to provide multiple doses. Each inventory rack
carousel 210 or 212 supports multiple inventory racks (not shown).
In some applications, an operator may remove one or more racks from
the carousels 210, 212 and replace them with racks loaded with
inventory. The racks may be loaded onto the carousels 210, 212
according to a load map, which may be generated by the operator for
submission to the APAS 100, or generated by the APAS 100 and
communicated to the operator. The chambers 202, 204 are
substantially separated by a dividing wall 216.
The processing chamber 204 includes a multiple degree of freedom
robotic arm 218, and the robotic arm 218 further includes a gripper
that can be used, for example, to pick items from a pocket on a
rack or to grasp items within the APAS 100 for manipulation. The
robotic arm 218 can respond to command signals from a controller
(not shown) to pick up, manipulate, or reposition inventory items
within the processing chamber 204, and in or around the carousels
210, 212. The robotic arm 218 can manipulate inventory items, for
example, by picking a vial, IV bag, or syringe from a rack of the
carousels 210, 212 in the inventory chamber 202, and moving the
item to a station in the processing chamber 204 for use in compound
preparation. In some examples, the robotic arm 218 manipulates
inventory items on the carousels 210, 212 through an access port
(not shown) in the dividing wall 216. The dividing wall 216 may be
substantially sealed so that a substantially aseptic environment
may be maintained for compounding processes in the processing
chamber 204.
According to an illustrative example, an incoming drug order from a
remote user station (not shown) involves a batch production order
for syringes to be charged with individual doses of a drug that is
reconstituted from a drug provided in one or more vials. The
operator, for example, preloads the drug into the APAS 100 during a
loading process by loading the carousel 210 with inventory racks of
the drug vials, and by interfacing with the APAS 100 using the
input/output device 102 to initiate, monitor, and/or control the
loading process. As the APAS 100 is processing a previous order,
the operator may load the carousel 212 with inventory racks of
syringes, drug vials, and IV bags for the next batch production
order while the APAS 100 is operating the carousel 210. Once the
loading process is complete, the operator may submit the batch
production process, which may begin immediately, or after other
processing is completed.
To execute the batch production, in this example, the robotic arm
218 picks a syringe from a pocket in a rack in carousel 210. The
syringe in the carousel includes a needle and a needle cap. The
needle cap is removed for processing in the APAS 100. The robotic
arm 218 conveys the syringe to a decapper/deneedler station 220
where the needle cap is removed from the syringe/needle assembly to
expose the needle. The robotic arm 218 moves the syringe to a scale
station 226 where the syringe is weighed to determine its empty
weight. The robotic arm 218 may transfer the syringe to a needle-up
syringe manipulator 222 where a dose of the drug is drawn from a
vial, which was previously placed there by the robotic arm 218
after one or more verification operations (e.g. weighing, bar code
scanning, and/or machine vision recognition techniques). The
robotic arm 218 moves the syringe to the decapper/deneedler station
220 where the needle is removed from the syringe and disposed of
into a sharps container (not shown). The robotic arm 218 then moves
the syringe to a syringe capper station 224, where the needleless
syringe is capped. The robotic arm 218 moves the syringe to a scale
station 226 where the syringe is weighed to confirm the
predetermined dose programmed into the APAS. The robotic arm 218
then moves the syringe to a printer and labeling station 228 to
receive a computer readable identification (ID) label that is
printed and applied to the syringe. This label may have a bar code
or other computer readable code printed on it, which may contain,
for example, patient information, the name of the drug in the
syringe, the amount of the dose, as well as date and/or lot code
information for the inputs. For example, the information printed on
the label can depend on the requirements of the hospital system for
patient dose labeling. The robotic arm 218 then moves the syringe
to an output scanner station 230 where the information on the ID
label is read by the scanner to verify that the label is readable.
The APAS 100 may report to the remote user station using a local
communication network, for use in operations planning. For example,
the APAS 100 may record the dispensing of the medicament for later
reporting to the hospital system. The syringe is then taken by the
robotic arm 218 and dropped into the syringe discharge chute 232
where it is available to the pharmacy technician, for example, to
be placed in inventory within the hospital pharmacy. As the process
continues, there may be times during the drug order process where
the robotic arm 218 removes an empty vial from the needle-up
syringe manipulator 222 and places it into a waste chute 233. For
example, while processing a drug order, the APAS 100 can use more
than one vial to process a single order. Therefore, the robotic arm
218 can dispose of the empty vial prior to replacement of a new
vial in the needle-up syringe manipulator 222.
In another illustrative example, a syringe is used both as an input
containing a fluid (e.g., diluent or known drug compound) to be
admixed in a compounding process, and as an output containing a
prepared dose suitable for delivery to a patient. Such a syringe is
needed to fulfill a special reconstitution order programmed into
the APAS 100 via the input/output capabilities of the monitor 102,
for example. In another example, the order is a stat order, which
is received from a hospital interface. In this example, the
operator performs in situ loading by placing the syringes to be
used for both reconstitution and dosing in pockets on a rack
already located on the carousel 210. The operator enters the
reconstitution order into the APAS 100. The robotic arm 218 picks
the selected syringe from a pocket in the rack in the carousel 210
and moves it to the decapper/deneedler station 220, where the
needle cap is removed from the syringe/needle combination, thereby
exposing the needle. The syringe is then transferred by the robotic
arm 218 to a needle-down syringe manipulator 234. At the station
234, diluent is drawn into the syringe from a diluent supply IV bag
236 previously placed there by the robotic arm 218. The diluent
supply 236 is contained in an IV bag, which is hung on the
needle-down syringe manipulator 234 by a clip (not shown). For
example, an air extraction process is performed to prime the IV
bag, if needed. The syringe then punctures the membrane of the
diluent port 238 in a needle-down orientation. The syringe is
actuated to remove, for example, a predetermined amount of the
diluent from the IV bag. The needle-down syringe manipulator 234
then moves a reconstitution vial 250, placed there previously by
the robotic arm 218, under the syringe. The diluent in the syringe
is transferred to the vial for reconstitution with the vial
contents. The robotic arm 218 then moves the vial to a mixer 248
for shaking according to a mixing profile. The robotic arm 218 then
moves the vial to the needle-up syringe manipulator 222 where the
appropriate amount of the reconstituted drug is drawn from the vial
into an "output" syringe that was previously conveyed there by the
robotic arm 218.
In another embodiment, the APAS 100 receives a production order to
prepare compounds that involve IV bags as input inventory items or
as outputs. In some examples, an IV bag is selected as a diluent
source for reconstitution in a drug order to be output into another
medical container. In other examples, the selected IV bag is used
for output after preparation of the drug order is completed. For
example, the IV bag is placed on the carousels 210, 212 and used as
an input that may be at least partially filled with a diluent that
may be used to reconstitute drugs. In some examples, the IV bag may
be previously unused and completely filled with the diluent. The
reconstituted drugs are output in the form of charged syringes or
IV bags. The operator loads racks of syringes and IV bags into the
carousel 210 for use in the production order. During the production
order, the robotic arm 218 picks an IV bag from a rack on the
carousel 210 and moves it to the scale and bag ID station 226. At
this station, the IV bag is identified by bar code or pattern
matching and its weight is recorded. For example, IV bag
identification is performed as an error check, and/or to positively
identify the type and/or volume of diluent being used for
reconstitution. If the IV bag is selected as a diluent source, then
the bag is weighed before use to confirm the presence of the
diluent in the IV bag. If the IV bag is selected for output, it is
weighed multiple times, such as before, during, and/or after each
fluid transfer step, for example. As a post-transfer verification
step, the weight is re-checked after fluid transfer operations have
occurred to determine if the change in weight is within an expected
range. Such checks detect, for example, leaks, spills, overfills,
or material input errors. In this example, the robotic arm 218
moves the IV bag to a port cleaner station 240 where a ultraviolet
(UV) light or other sanitizing process is used to substantially
sterilize, disinfect or sanitize at least a portion of the IV bag
port. The robotic arm 218 moves the IV bag to the needle-up syringe
manipulator 222 where a pre-filled syringe has been loaded. The IV
bag is inverted so that the fill port is oriented downwardly for
the fill process. The contents of the syringe is injected into the
IV bag. The robotic arm 218 then conveys the IV bag to the scale
station 226 where the IV bag is weighed to confirm the
predetermined dose programmed into the APAS 100. The robotic arm
218 then moves the IV bag to a bag labeler tray station 242 where a
label printed by the printer and labeling station 228 is applied to
the IV bag. The robotic arm 218 moves the IV bag to the output
scanner station 230, where the information on the ID label is read
by the scanner to verify that the label is readable. One or more
further verification checks may be performed. For example, the
output scanner station 230 can compare the scanned label
information to the expected label information to verify that the
correct medicament is being dispensed. The IV bag is then taken by
the robotic arm 218 and dropped into the IV bag discharge chute 244
where it is available to the pharmacy technician, for example, to
be placed in inventory within the hospital pharmacy.
In another embodiment, a vial (or other medical item or container)
is prepared for reconstitution. During the performing of this
process by the APAS 100, the vial is identified at a vial ID
station where, for example, a bar coded label on the vial is read
by a scanner and/or image hardware in combination with image
processing software. The captured information is processed to
identify the contents of the vial and correlate it to what is
expected. In some implementations, as an alternative to or in
combination with bar code scanning, the APAS 100 employs pattern
matching on the vial using optical scanning techniques. In
addition, in the reconstitution process, vial mixers 248 are used
to mix the vial contents with the diluent before using it for
dosing.
In some embodiments, the robotic manipulator includes apparatus for
reading machine readable indicia in the APAS, including the
compounding chamber and/or the storage chamber. For example, the
manipulator includes an electronic camera for taking images that
can be processed to compare to stored image information (e.g.,
bitmaps). In other examples, the images may be stored without any
additional processing. In other examples, the reading apparatus
includes optical scanning (e.g., bar code) or RFID (radio frequency
identification). Some embodiments transmit image information
wirelessly (e.g., using infrared or RF (radio frequency)
transmissions) to a receiver coupled to the APAS. For example, the
receiver is located inside or outside the chamber with the robotic
manipulator. For example, the reader is used to read machine
readable indicia at various locations in and around the compounding
chamber, including through windows and on portions of the storage
carousels that are exposed to the compounding chamber.
Intermediate IV Bag Handling
Intermediate bag functionality enables the APAS to use previously
prepared IV bags (intermediary bags) as drug sources for creating
patient doses in syringes. The APAS creates a dosed syringe at a
lower concentration than that available when using the syringe to
dilute the concentration of drugs.
The use of an intermediary bag to create a dosed syringe is a
two-step process. In a first step, a user defines, trains, and
creates a new drug source type. The APAS uses a front end form in a
training wizard to train a new drug source by defining the diluent
and drug source to be used and a final concentration and bag volume
for the intermediary bag. When training for a new drug source
introduced by an intermediary bag, a final volume is an absolute
value with respect to the total volume of the intermediary bag.
Alternatively, when training for the new drug source introduced by
the intermediary bag, a final volume is the total volume of the
intermediary bag that includes the new drug source.
A created intermediary bag is output from the APAS for possible
later use in the APAS. The APAS creates the intermediary bag in a
final volume bag by controlling the amount of fluid (diluent) and
the amount of drug in the bag. In creating the intermediary bag,
the APAS weighs a diluent bag, determines the amount of fluid in
the bag, withdraws an amount of fluid required to reduce the amount
of fluid in the bag to a specified amount, and adds a specific
amount of drug to the bag. The APAS at a syringe manipulation
station then removes an amount of diluent necessary to accurately
make the intermediary bag at the absolute final volume entered by
the user into the front end form in the training wizard.
For example, to produce a concentration of 20 ml of drug in a final
volume of 200 ml of normal saline (NS) to create an intermediary
bag, the APAS can use an existing 250 ml bag, weigh the bag to
determine it contains 272 ml of NS, withdraw 92 ml of fluid from
the bag, discard the withdrawn fluid, and add 20 ml of drug to the
bag to create an intermediary bag that includes a diluted drug
source with a final volume of 200 ml.
A user operating a workstation interfaced to the APAS can launch a
drug order that will use the produced intermediary bag. The user
launches the drug order using a hospital interface (patient
specific). Alternatively, the user launches a drug order using a
front end drug order form (non-patient specific).
In some implementations, the APAS creates intermediary bags at off
peak use times for the APAS. The APAS outputs the intermediary bags
with an appropriate label. Alternatively, the APAS outputs the
intermediary bag without a label where the label is printed and
applied external to the APAS (e.g., an operator takes a printed
label and affixes it to the intermediary bag). For example, an
intermediary bag can be characterized by it's drug name,
concentration and final volume.
The APAS accepts a single or multiple entries of a single
intermediary bag. When outputting multiple entries of a single
intermediary bag, the size of the intermediary bag is selected to
minimize waste of unused drug source. For example, the APAS creates
four 250 ml intermediary bags compared to making a single one liter
bag.
To create an intermediary bag with an accurate final volume, an
initial or "empty bag" weight is determined for each size fluid
diluent bag used to create an intermediary bag. The APAS controller
uses the empty bag weight to determine a total volume amount that
may include an overfill amount for the diluent bag. The APAS
controller in a volume adjustment step determines how much of the
total volume in the diluent bag can be removed to obtain the
trained final volume for the intermediary bag. The user monitors
any manufacturer changes in diluent bags used by the APAS and also
insures that diluent bags introduced into the APAS are intact.
A user uses an intermediary bag training wizard to train the APAS
to use an intermediary bag. The user uses a user interface included
in the APAS and described with respect to, for example, FIG. 2 of
previously incorporated by reference U.S. patent application Ser.
No. 11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006, to enter a drug type, a
diluent type and a diluent bag volume (bag size and type) for
training the intermediary bag on the APAS. While training the APAS,
the user enters a final volume and concentration for the
intermediary bag and a draw volume adjustment that specifies how
much volume to remove from the intermediary bag (e.g., when drawing
doses from the intermediary bag into a syringe).
The final volume of the intermediary bag can be greater than that
for an original diluent bag and may be less than the volume
specified by the APAS for a maximum allowable volume for the
original diluent bag. An IV bag has an overfill value that is added
to the total allowed volume for the IV bag. For example, an
allowable volume for an IV bag type is set based on manufacturers'
data.
The APAS controller assigns a newly trained intermediary bag a
unique "type number." The type number can be unique for a trained
intermediary bag type but may not be unique for each of the same
type intermediary bags produced. For example, the APAS produces an
intermediary bag that includes a concentration of 20 ml of a
specific drug in a final volume of 200 ml of NS. This newly trained
intermediary bag is assigned a unique type number 101. Additional
intermediary bags produced by the APAS that include a concentration
of 20 ml of the same drug in a final volume of 200 ml of NS are
assigned the same type number 101 when trained in the APAS. The
user uses the type number when reloading the intermediary bag into
the APAS. The type number becomes the "name" for the specific
intermediary bag type.
The user sets one or more expiry times (e.g., a time in minutes,
days, hours, weeks, months, etc.) for an intermediary bag. The
expiry time for the intermediary bag begins from the time of the
first access of the intermediary bag (e.g., the first puncture of a
port on the intermediary bag with a needle of a syringe).
Alternatively, the expiry time for the intermediary bag begins from
the time of the first puncture of any of the constituents to be
used for the production of the intermediary bag. The expiry times
are trained expiry times entered by the user when training the APAS
to use the intermediary bag.
The APAS controller validates the expiry time for the intermediary
bag. The expiry times for the products (e.g., drugs, diluent) used
to produce the intermediary bag are taken into account when
determining the expiry time for the intermediary bag. Additionally,
any refrigeration or freezing times associated with products used
to produce the intermediary bag can be taken into account when
determining the expiry time for the intermediary bag. An expiry
time is set to start at the moment the intermediary bag is output
from the APAS. The expiry time is checked when the intermediary bag
is loaded back into the APAS to insure that the bag is still within
the expected expiry time. A second expiry time begins to track how
long the intermediary bag is used to draw doses from within the
APAS. For example, a first expiry time can be 9 days so that once
the bag is made there can be a 9 day window to allow reentry of the
bag into APAS. In another example, once loaded, a new expiry time
of 24 hours, can insure that doses are not drawn from the bag after
24 hours. The first expiry time can reduce the second expiry time
in the event the in the cell time is longer than the out of cell
time remaining.
When training the APAS to use an intermediary bag, the puncture
limit (e.g., the number of times a port can be accessed by a needle
on a syringe) for the intermediary bag is the same as or less than
the puncture limits for the original source fluid IV bag used to
created the intermediary bag. The user sets the puncture limit for
the intermediary bag.
FIG. 3 shows an example table 300 for minimum and maximum fill
sizes for an intermediary bag. In some implementations, original
source fluid bags that contain less than 25 ml are not used. In
some implementations, the minimum drug dose that is put into any
size of a source fluid bag is 1.8 ml. The minimum fill size limits
are determined based on the accuracy of the scale in the APAS used
to weigh the bags during processing. The minimum amount of fluid
that remains in an intermediary bag during a volume adjustment step
in the APAS is, for example, 20% of the nominal bag volume. For
example, a 100 ml bag can be drawn down where 20 ml of fluid
remains in the bag (e.g., 80 ml of fluid can be removed from the
bag) before the desired amount of drug is added to the bag to
produce the intermediary bag.
When training an APAS to use an intermediary bag, a draw volume
adjustment specifies how much volume is removed from the
intermediary bag when drawing doses from the bag. A negative draw
volume adjustment indicates drawing a volume amount that is less
than what is specified as the final volume of the intermediary bag.
A positive draw volume adjustment indicates drawing a volume amount
that is more than what is specified as the final volume of the
intermediary bag. A positive draw volume amount may not be used as
the final volume of the intermediary bag as it may not include an
overfill adjustment value.
A user trains the APAS to use intermediary bags with a weigh after
prime flag initially set to ON. Setting the weigh after prime flag
to ON enables the APAS to gather statistical information on the
amount of fluid removed during an IV bag priming process. This may
decrease the number of potential overdraw failures that occur in
the APAS when drawing doses from the intermediary bag. Reweighing a
bag after the priming step allows a more accurate weight of the
total bag to be recorded for later use in adjusting the amount of
diluent in the bag.
The APAS can create and produce one or more intermediary bags one
at a time or in a batch mode using front end non-patient specific
drug order forms. This enables the batch production of a plurality
of one bag type or multiple different bag types within the same
batch order. A user enters values into a production queue table
that enables the user to select a drug source, a diluent source, an
intermediary bag concentration and a desired number of doses for
the intermediary bag. After entering the values into the production
queue table, the APAS controller creates a production queue that
the APAS cell uses for making the intermediary bags where the
sequence of process steps for loading and preparing the inventory
needed for the intermediary bag production parallels that of a
non-intermediary or standard queue for creating a drug order.
In an illustrative embodiment, when producing an intermediary bag,
a robotic arm removes a diluent bag from inventory (e.g., remove a
diluent bag from an inventory carousel), the APAS controller
verifies, for example, the bag stem height, the robotic arm places
the bag in the UV port sanitization system, the APAS controller
verifies that the bag is that expected by checking, for example,
the National Drug Code (NDC) barcode of the diluent bag at a bar
code scanner and the initial weight of the diluent bag is checked
at a scale. If the diluent bag passes the verification checks, the
robotic arm moves the diluent bag to a syringe manipulator device
where the diluent bag can be primed to remove air. The bag priming
process is described in FIGS. 15A-15C of previously incorporated by
reference U.S. patent application Ser. No. 11/389,995, entitled
"Automated Pharmacy Admixture System," and filed by Eliuk et al. on
Mar. 27, 2006. Additionally, the robotic arm removes vials from
inventory (e.g., remove a vial from an inventory carousel) and
verifies the vial identification information and height at an
identification station. The robotic arm places the vial in the UV
port sanitization system, the vial is weighed on a scale, the vial
is reconstituted (when applicable) and then the robotic arm parks
the vial once complete.
The empty weight of an IV bag is used in determining how much
diluent to withdraw when making the intermediary bag. IV bags
typically contain overfill from their nominal fill volume (eg, a
100 ml bag may contain 110 ml of diluent). Accounting for this
overfill, which may change from bag to bag, is important to ensure
that the correct amount of diluent is withdrawn. In addition,
accuracy may further be enhanced by weighing the bag after the
priming step. The total weight of the bag is the empty weight of
the bag plus the weight of the fluid in the bag. As the fluid
density of the diluent is trained into APAS, the volume of diluent
is calculated by subtracting the empty weight of the bag from the
total weight and converting diluent weight to volume using the
diluent density. Once the volume of diluent in the bag is known,
the appropriate amount is extracted to achieve the desired amount
of diluent in the IV bag.
An empty IV bag is used to prepare an intermediary bag. For
example, an empty 150 ml IV bag is used to make an intermediary bag
that contains 100 ml of drug and 50 ml of diluent. In cases where
the amount of diluent is small, starting with an empty bag may be
efficient from a production time perspective.
The APAS adds additional diluent to an IV bag already containing
diluent to achieve the desired amount of diluent in the bag. For
example, 50 ml of diluent is added to a 500 ml bag, which actually
contains 530 ml of fluid, to provide a total of 580 ml of diluent
to dilute 10 ml of drug in. This is more efficient from a
production time perspective than drawing 400 ml or more of diluent
from a 1000 ml IV bag to achieve the same amount of diluent in the
IV bag.
FIG. 4 shows an example vial parking location 400 in an APAS. The
APAS, in order to prevent software conflicts between preparing
diluent bags on the syringe manipulator device and reconstituting
vials on the syringe manipulator device, first reconstitutes the
vials and then parks them (e.g., on vial parking shelves in vial
parking location 400) before preparing the diluent bags. The APAS
removes existing vials from the vial parking shelves and places
them on a reject rack if additional parking positions are needed on
the vial parking shelves to complete a production queue for the
production of an intermediary bag.
FIG. 5 shows an example syringe manipulation device 500 that
includes a liquid waste drain tube 502. FIG. 6 shows an example
liquid waste container 600. The diluent bag is weighed on a scale
after priming to ensure the accuracy of the diluent volume
adjustment for the intermediary bag. The syringe manipulator
station extracts the appropriate amount of diluent from the bag
needed to create the trained final volume for the intermediary bag
less the total drug volume that the APAS adds to the bag to create
the intermediary bag. The APAS uses an extraction syringe and
needle (e.g., syringe 504 and needle 506) to dispense the discarded
liquid into a liquid waste drain tube (e.g., liquid waste drain
tube 502) located on the syringe manipulator device (e.g., syringe
manipulator device 500). The liquid waste drain tube 502 drains the
discarded fluid into the liquid waste container 600 located in a
waste bin area of the APAS. A user can regularly empty the liquid
waste container 600 during APAS idle times.
FIG. 7 shows an example IV bag parking location 700 in an APAS. The
robotic arm places a volume-adjusted diluent bag 702 in an IV bag
parking location 700 in the APAS. The APAS commands the syringe
manipulation device to draw a specific amount of a drug from an
appropriate vial. One or more vials are used to obtain the specific
amount of drug needed to produce the intermediary bag. The number
of vials may be limited based on the number of available vial
parking shelves to hold the vials needed to produce the
intermediary bag.
For example, the APAS moves the diluent bag from its parked
position back to the syringe manipulation device. The amount of
drug drawn into the syringe at the syringe manipulation device is
introduced (e.g., pushed) into the volume-adjusted diluent bag
creating the intermediary bag. After adding the drug to the
volume-adjusted diluent bag, the APAS checks the weight of the
intermediary bag to verify accurate dosing.
The APAS labels the intermediary bag with a intermediary bag label.
The intermediary bag label includes a type number that the APAS
uses when reloading the intermediary bag back into the APAS. The
APAS prints a bar code that includes the type number on the
intermediary bag label. The APAS reads the bar code and uses the
encoded information to identify and verify the intermediary bag
when a user reloads the intermediary bag back into the APAS. For
example, the intermediary bag label includes a line for an approval
signature and a blank line to allow hand addition of any additional
information. In another example, the label printer prints the
intermediary bag expiry dates on the intermediary bag label. When
loading an intermediary bag into the APAS, a user selects
intermediary bags closer to their expiry date to load first into
the APAS.
If the intermediary bag passes the verification checks, the robotic
arm places the intermediary bag in the output chute for delivery to
the user. If the intermediary bag fails one or more verification
checks, the robotic arm places the intermediary bag on a reject.
The APAS may apply a label to the rejected bag indicating the
reason it failed verification (e.g. incorrect mass/volume of
diluent or drug).
Diluent used to reconstitute a drug vial is obtained from an IV bag
different from the source diluent bag for the intermediary bag. The
APAS performs fluid cycling with the syringe at the syringe
manipulation device after drug injection into the source diluent
bag to move drug out of the neck of the bag and into the body of
the bag. A user performs adequate mixing of the drug and diluent in
the intermediary bag while handling the intermediary bag outside of
the APAS.
The following describes, in some implementations, the use of an
intermediary bag in the APAS to produce a drug order. Upon
receiving one or more drug order(s) that require the use of one or
more intermediary bag(s), the APAS requests the user to load
specific type numbers of intermediary bags into the APAS. For
example, the type number can be included on the intermediary bag
label. The APAS reads the intermediary bag label (e.g., the bar
code printed on the intermediary bag label using a barcode
scanner). The APAS uses the data read from the intermediary bag
label (e.g., bar code label data read by the bar code scanner) to
determine if the user is loading the correct intermediary bag into
the APAS. Additionally, the APAS determines the drug order
identification (e.g., DrugOrderID) of the intermediary bag.
The APAS uses one or more intermediary bags to produce a single
output ordered dose. If a first intermediary bag is emptied during
dose preparation, a second intermediary bag is used to complete the
dose preparation. The robotic arm parks or stores a partially used
intermediary bag in IV bag parking for use in a later subsequent
drug order process. If a parked intermediary bag needs to be
removed for drug priority reasons, it is placed on the reject rack.
A user ensures that an adequate number of the required intermediary
bags are available before the user begins a drug order run on the
APAS. If the APAS requires the use of another intermediary bag
during the drug order run and the bag is not available, the user
stops the drug order run.
When drawing a dose from an intermediary bag for the first time,
the APAS primes the intermediary bag using the syringe selected for
the preparation of the dose. The priming of the intermediary bag by
the APAS removes any air in the intermediary bag that may have
migrated from the additional port on the intermediary bag.
In some implementations, the APAS recovers from initial failures
during the use of an intermediary bag in a drug order run. The APAS
recovers from an initial bag weight failure. This failure occurs
when the current weight of a bag compared to the previous weight of
the bag when prepared do not agree. The APAS recovers from an error
resulting from the attempted use of an expired bag. In order to
recover from this error, additional bags of that type need to be
available for use by the APAS. The APAS recovers from a height
check failure and from a barcode verification check failure. The
APAS recovers from an error that may occur while priming the
diluent bag. Error handling and recovery in an APAS is described in
further detail with reference to FIG. 31.
A user performs available volume training for vials and bags on an
APAS. The available volume of a drug is the volume of the drug that
can be physically drawn from a drug source container (e.g., a vial
or bag). The available volume is a result of physical
characteristics of the drug source container. The APAS may not be
able to remove all of the available drug from the drug source
container. A user of the APAS can specify a maximum available
volume of a liquid to draw from the drug source container where the
specified maximum available volume for the draw is different than
the amount specified on the original source container drug label.
The possible difference between the maximum available volume for
draws and the amount specified on the drug source container occurs
for intermediary bags as well as the additional drug source
container. For example, a user specifies 9.8 milliliters (mls) of
fluid be drawn from a 10 milliliter (ml) vial, leaving 0.2 mls of
liquid in the vial as the APAS may not be able to remove all of the
liquid from the vial.
A user specifies a different available volume in a drug source
container than specified on the actual drug source container. A
remote user station prompts the user for the actual drug source
used. The APAS allows for compensation for overfill of a drug
source container. The user specifies the available volume in a drug
source container when training diluent sources on the APAS. When
training intermediary bag sources on the APAS, the user also
specifies the available volume in the intermediary bag source
container, which may be different from the volume specified for the
original diluent bag source container used to produce the
intermediary bag. When training drug vial sources on the APAS, the
user specifies the available volume in the drug vial.
The APAS database generates a drug report that indicates the
original source diluent bag and vial that the APAS used to produce
the intermediary bag. For example, a picture of the resultant
intermediary bag is used in the drug report. The APAS database
creates a report that indicates how many non-expired intermediary
bags are expected to be stored outside the APAS. The report
indicates what the APAS can expect to occur outside of the
APAS.
The APAS controller performs diluent bag volume adjustment
verification. Each diluent bag source has a prescribed minimum
volume and maximum volume to which it is adjusted. The APAS
controller uses average dry weight data for each diluent bag source
part number or type to calculate an estimate of the fluid volume in
the diluent bag. The APAS reweighs diluent bags after priming on a
scale. Alternatively, if the APAS does not reweigh diluent bags
after priming, the APAS controller uses an average priming volume
to calculate the fluid adjustment volume for the diluent bag. The
adjusted fluid volume is confirmed by weight, employing the density
numbers for the applicable fluid.
FIG. 8 shows an example adjusted volume weight verification
interpolation table 800 used to perform diluent bag volume
adjustment verification. The limits for deviation from the expected
fluid weight of a diluent bag are interpolated from table 800 based
on the size of the dose or amount of fluid removed from the diluent
bag by a syringe. The limits included in the table 800 may be
smaller than the specified accuracy limits due to allowance for
scale inaccuracy.
Column 802 includes information about the type of syringe used to
remove the dose from the diluent bag. An APAS supports a plurality
of syringe types. The APAS can associate each syringe type (e.g.,
seven syringe types) with a number (e.g., a number from one to
seven, respectively). In the example in table 800, syringe type
number four is used.
Column 804 includes information about the percentage of the syringe
nominal volume that the expected fluid weight of the diluent bag
can vary. In the example table 800, this percentage is 10%. The
percentage of the syringe nominal volume can be a number from
approximately 0.1 to 1.0 (10% to 100%)
Column 806 includes information about the percentage of error
tolerance for a fluid adjustment when the diluent bag is reweighed
after the bag is primed. In the example table 800, the error
tolerance is plus or minus (.+-.) 4.0%. The variation of .+-.4.0%
is applied to the nominal weight or volume of the diluent bag
remaining fluid to generate a maximum and a minimum weight
limit.
Column 808 includes information about the percentage of error
tolerance for a fluid adjustment when the diluent bag is not
reweighed after a dose is removed from the bag. In the example
table 800, the error tolerance is plus or minus (.+-.) 8.0%. The
variation of .+-.8.0% is applied to the nominal weight or volume of
the diluent bag remaining fluid to generate a maximum and a minimum
weight limit. The percentage of error tolerance for a fluid
adjustment when the diluent bag is not reweighed after priming can
be larger than the percentage of error tolerance for a fluid
adjustment when the diluent bag is reweighed after priming to allow
for the variation in an unknown priming volume. The priming volume
is unknown when the diluent bag is not weighed after priming.
The APAS performs intermediary bag drug injection verification. A
syringe can draw injected drug doses according to existing syringe
manipulation device draw-from-vial parameters. The dose limits for
volume (or weight) are verified against a table included in the
database of the APAS based on the size of the dose and the size of
the syringe used for the dose. The intermediary bag expected
nominal delta weight is corrected for fluid lost to syringe dead
space due to syringe cycling. The APAS applies error limits to the
corrected volume where the error limits are derived from the
expected fluid transfer prior to correction. The assumed density of
the fluid is the weighted average of diluent and drug densities.
The dead space volume is unique per syringe type. After
neck-expunge cycling of the syringe, the syringe dead-space is
filled with diluted drug. There may be a minimum dose volume for
each unique diluent bag type. Software in the APAS confirms that
the minimum dose requirement is satisfied using weight
verification.
The APAS performs intermediary bag cell reentry verification. When
the user loads an intermediary bag into the inventory chamber, the
APAS controller verifies the intermediary bag weight using a
measured final weight for that intermediary bag at the time of
production of the intermediary bag. In some cases, condensation
makes the intermediary bag heavier. In some cases, evaporation
makes the intermediary bag lighter. Additionally, the weight of the
intermediary bag on reentry to the APAS is corrected for the weight
of the intermediary bag label, which is applied after the APAS
performs a final weight measurement during production of the
intermediary bag. The weight correction uses an average label
weight stored in the database in the APAS. For example, a bag label
weight is approximately 0.350 g. A reentry-weight tolerance is a
number (e.g., in grams) for each trained intermediary bag type. The
APAS controller performs an intermediary bag drawn syringe dose
verification that uses an existing syringe manipulation device
bag-source syringe-draw verification.
If an intermediary bag fails in the APAS for any reason after the
bag identification verification, the intermediary bag is not
reloaded into the APAS in a subsequent run and the intermediary bag
is placed in the reject bin. If an intermediary bag fails the bag
identification verification, it is reloaded into the APAS in a
subsequent drug order run. This failure indicates that the user
attempted to load an incorrect intermediary bag into the APAS. The
integrity of the drug in the intermediary bag in the case of this
error may not be in question allowing for reuse of the intermediary
bag.
In some implementations, the intermediary bag is not produced in
the same drug order run as it is used for. This enables the APAS to
output the intermediary bag to the user for mixing and any other
additional handling. The user queues up a subsequent drug order to
use the produced intermediary bag. In some implementations, the
APAS uses one or more intermediary bags to complete a drug dose
order.
When a user has trained the APAS for a particular type of
intermediary bag that has been entered into the APAS, the APAS may
not allow subsequent changes to the definition of the intermediate
bag by the user. Not allowing the user to redefine the intermediary
bag after initial training prevents a previously made intermediary
bag from re-entering the APAS with an incorrect concentration. For
example, the APAS is trained for a particular intermediary bag at
one concentration, a definition change changes it to a different
concentration, an intermediary bag with original concentration is
re-entered into the APAS as the same type, but the APAS now assumes
the intermediary bag will have the second specified
concentration.
The APAS eliminates the possibility of a user loading an
intermediary bag into the APAS as a diluent bag allowing the
intermediary bag to go through the initial bag identification
checks. For example, the APAS ensures that produced intermediary
bags do not have the same initial weights as diluent bags. In this
example, the initial bag weight check fails an intermediary bag if
it is erroneously loaded into the APAS as a diluent bag.
Additionally, the user does not have access in the APAS to change
diluent bag weights, ensuring these weights are not accidentally
changed. For example, the weights are updated in the APAS based on
data gathered from the APAS and bag manufacturer data. The bag
empty weights can insure accurate bag volume estimations are
preloaded on the APAS.
For example, a user obscures the bag manufacturer's National Drug
Code (NDC) barcode on the printed side of the intermediary bag to
ensure that it does not pass the bag identification bar code scan
check. In this example, the user applies a blank label or some
other type of masking device over the bag manufacture's NDC barcode
after the production and delivery of the intermediary bag to the
user to obscure the bag manufacture's NDC barcode from the bar code
scanner in the APAS.
In some implementations, an intermediary bag is agitated (e.g.,
mixed) after the intermediary bag leaves the APAS for the first
time and also before the intermediary bag is reloaded into the APAS
or used externally from the APAS. The agitation ensures adequate
mixing of the drug and diluent within the intermediary bag.
Vial Seal Puncturing
For purposes of illustration of example embodiments, references are
made below to the APAS, which has been used in various experiments
as described herein. The APAS accommodates a very large assortment
of drug vials to perform aseptic compounding of IV medications.
These drug vials can utilize rubber stoppers, or bungs, with a wide
range of geometric features and rubber properties. Furthermore,
properties of the bung rubber can vary batch to batch of drug
vial.
FIG. 9 is an illustration of an example of a Becton Dickson (BD) 18
gauge blunt fill needle 900 (Part Number 305180). The needle 900
includes a primary edge 902 and a secondary edge 904. A syringe
uses the needle 900 to transfer fluids through vial and bag bungs.
The needle 900 is used in pharmaceutical compounding.
A syringe manipulator device performs a process that includes
repeated entry through the same vial puncture site with careful
control of needle position, needle bevel orientation, and needle
entry speed. The process yields beneficial results with respect to
bung pressure sealing (with and without needle engagement) and with
respect to the tendency to generate particulate. Particular vial
bungs lack resilience. The bung properties may make them much more
prone than other types of bungs to generate particulate under
repeated puncture. The bungs may be more susceptible to cutting
from the needle-bevel secondary edge (e.g., secondary edge
904).
Various experiments were performed to explore and develop various
means to improve the performance of identified poorer performing
bungs with respect to multiple needle punctures.
A first experiment involved the control of needle entry speed.
Along with other associated measures, the reduction of needle
engagement speed reduces secondary edge (e.g., secondary edge 904)
cutting and generation of particulate. Needle engagement speeds
below 30 millimeters/second (mm/sec) and even below 1 mm/sec
preserve bung integrity. Typical practical needle engagement
operating speeds are in the range of approximately 5 mm/sec to
approximately 1 mm/sec Needle disengagement speeds may not be a
major factor in bung performance. Needle disengagement speeds
affect leakage during disengagement. The faster the disengagement
speed the more likely leakage may occur.
FIG. 10 is an illustration of a vial 1000 and a needle 1002 with a
co-aligned axis. A second experiment involved the control of needle
to vial engagement angles and needle movement variations. In some
implementations, the APAS operates with a co-aligned needle and
vial axis with engagement movement being along the axis (e.g.,
direction of motion is shown by arrow 1004). Variations of the
coaxial alignment improve bung puncture performance.
FIG. 11 is an illustration of a vial 1100 and a needle 1102 with
the vial axis canted relative to the needle axis. The vial is
canted (e.g., vial angle 1106) in the direction of a needle bevel
1108. Engagement movement of the needle 1102 into the vial 1100 is
along the axis of the needle (e.g., arrow 1104 shows the direction
of motion).
For example, the vial angle 1106 varies from zero degrees to 45
degrees. A vial angle 1106 of zero degrees constitutes a normal
engagement case and a vial angle 1106 of 45 degrees approaches a
practical upper limit. A vial angle 1106 of 50 degrees approaches
the angle of the needle bevel 1108. An useful range of angles
includes angles between 10 to 30 degrees. For example, a nominal
vial angle is approximately 20 degrees. If the vial angle 1106 is
too small, secondary edge cutting of the bung by the secondary edge
of the needle (e.g., secondary edge 904 of needle 900 in FIG. 9)
occurs. If the vial angle 1106 is too large, the primary edge of
the needle (e.g., primary edge 902 of needle 900 in FIG. 9) slips
before engagement, has difficulty engaging, and generates adverse
needle sideways preload. For vial angles ranging from 15 degrees to
20 degrees, needle entry is optimized and evidence of secondary
edge cutting of the bung is diminished below concern. For example,
a vial angle of 20 degrees is a good compromise.
Additionally, samples of poor performing bungs were tested. Tests
were performed with the vial angle set to 15 degrees and 20 degrees
and the results were compared. A syringe manipulation unit included
in an APAS (an example of which is shown with reference to FIG. 6
of previously incorporated by reference U.S. patent application
Ser. No. 11/937,846, entitled "Control of Fluid Transfer
Operations," and filed by Doherty et al. on Nov. 9, 2007) performed
twenty punctures of a needle through a bung on a vial. For each
test, a new needle with a syringe was loaded on the syringe
manipulation unit and used for the entire test. The syringe
manipulation unit repeatedly cycled the bung, mounted on the vial,
onto the needle at a speed of 3 mm/sec for both engagement and
disengagement. Test results for both a vial angle of 15 degrees and
20 degrees showed that bung integrity was maintained. Additionally,
magnified imagery showed the bung punctured by the needle at a 20
degree angle exhibited less secondary edge scraping (e.g., scraping
of the secondary edge 904 of needle 900) towards the entry point of
the needle into the bung.
Vial bungs have surface features (indents) that identify puncture
sites for the user. The surface features either locally increase or
reduce the local entry angle of the needle into the bung. An
increase in the vial angle (e.g., vial angle 1106) provides
additional entry angle margin.
The techniques described for puncturing a vial with a beveled
needle require accurate guidance of the needle tip into the same
hole in the bung. The syringe manipulator device accomplishes
accurate guidance of a needle tip into the same hole in a vial bung
by using positive alignment of the needle with needle gripper
fingers (e.g., example needle gripper fingers are shown with
reference to previously incorporated by reference U.S. patent
application Ser. No. 12/209,097, entitled "Gripper Device," and
filed by Eliuk et al. on Sep. 11, 2008). The APAS accomplishes
accurate guidance of a needle tip into the same hole in a vial bung
by providing accurate registration of the vial top by gripping the
vial directly at the top of the vial. Examples of vial gripper
fingers are shown with reference to FIG. 6 of previously
incorporated by reference U.S. patent application Ser. No.
11/937,846, entitled "Control of Fluid Transfer Operations," and
filed by Doherty et al. on Nov. 9, 2007.
For example, a vial angle is negative (e.g., -20 degrees) and the
vial is angled in a direction opposite the needle bevel. This
configuration can exhibit beneficial particulate reduction. Other
variations of vial angles are possible through variations of the
axis of movement of the vial. Movement of the vial along the
syringe axis can engage the vial without bending the needle.
FIG. 12 is an illustration of a vial 1200 and a needle 1202 with
the needle axis canted relative to the vial axis. The initial
needle engagement motion into the vial occurs with a first movement
direction (e.g., indicated by arrow 1204) of the vial parallel to
the needle bevel direction. Once the needle penetrates the bung,
the motion changes to a second movement direction along the needle
axis (e.g., indicated by arrow 1206) to further penetrate the bung.
The needle rotates through all or some portion of a needle bevel
angle 1208 to align the needle and vial axes prior to a second
movement.
Other example methods to improve vial puncture performance include
automated control of puncture motion trajectories. A needle
includes a closed distal end and a number of radially directed
apertures along the needle shaft to facilitate fluid transfer
through the needle.
The APAS includes an assortment of drug vials used to perform
aseptic compounding of medications. The drug vials include rubber
stoppers, or bungs, with a wide range of geometric features and
rubber properties. The rubber properties may vary from batch to
batch of drug vials.
In some experimental configurations described below, the APAS uses
the needle 900 described in FIG. 9 to transfer fluids into drug
vials through the vial bungs. For example, the APAS performs
repeated entry of a needle through the same vial puncture site with
careful control of needle position, needle bevel orientation, and
needle entry speed. The APAS controls the repeated entry of a
needle through the same vial puncture site by positive alignment of
the needle with the needle gripper fingers, registration of the
vial top by directly gripping the vial at the top of the vial and
the use of a bevel orientation device. An example of a bevel
orientation device is shown in FIGS. 4A-4D of the previously
incorporated by reference U.S. patent application Ser. No.
11/937,846, entitled "Control of Fluid Transfer Operations," and
filed by Doherty et al. on Nov. 9, 2007. Controlling the repeated
entry of a needle through the same vial puncture site in this
manner may yield improved bung pressure sealing (with and without
needle engagement) and little or no particulate generation.
The syringe in an APAS uses one or more alternative needle designs.
For example, the APAS performs one or more seal punctures of fluid
ports of sealed pharmaceutical containers (e.g., IV bags, bottles,
drug vials) using a needle with a closed distal end (referred to as
"pencil point"). Analysis and experiments were performed that
involved several tip shapes, side port geometries and point
sharpness levels.
FIG. 13 is an illustration of an example pencil point needle 1300
inserted into a vial bung 1302 of a top of a vial 1304. As used
herein (unless otherwise indicated), a pencil point needle (e.g.,
pencil point needle 1300) includes a closed cone or parabolic
shaped point 1306 at a distal end through which no fluid flows. The
fluid path is through one or more apertures or side ports (e.g.,
side port 1308) located on the cylindrical portion of the pencil
point needle 1300. The side ports are located as close to the point
transition as possible. The vial bung 1302 acts as a stopper,
preventing fluid flow from the vial but allowing needle entry into
the vial.
The APAS performs one or more seal punctures of fluid ports of
sealed pharmaceutical containers that involve a puncture motion
trajectory using a pencil point needle. The APAS includes the
capability to puncture a vial many times without causing
substantial particulate, coring and/or leaks. By allowing higher
puncture counts, some implementations of the APAS are able to
increase the size of a container used to compound a drug. For
example, the use of larger containers by the APAS simultaneously
reduces the number of containers and other time and consumables
required to prepare a given number of doses of a drug the APAS. The
reduced operations and consumables may substantially reduce
operating cost, save energy, and yield higher throughput for the
APAS. The throughput gains achieved by the use of larger containers
may reduce handling and may reduce the number of vial
identification and disinfection processes. Furthermore, reducing
degradation of the seals over repeated fluid transfer operations
allows for an increase in needle size (e.g., diameter), which
yields improved fluid transfer rates and may further enhance
throughput.
In various embodiments, a suitable pencil point needle may not have
a bevel on the distal tip of the needle (e.g., pencil point needle
1300). Therefore, the APAS may not require a bevel orientation
device, which results in further improvements to throughput and
reduced system cost.
The example in FIG. 13 shows a potential partial leak problem that
occurs when the side port 1308 of the pencil point needle 1300 is
positioned and extended to provide fluid communication (e.g., shown
by arrow 1310) from an interior seal surface 1312 of the vial bung
1302 to the exterior seal surface 1314 of the vial bung 1302.
Various pencil point needles can be selected with side port
configurations that do not allow a fluid path when partially
inserted into a vial bung. A partial leak situation occurs during a
slow insertion and/or removal of the pencil point needle from the
vial bung. The partial insertion leak is further compounded when
coupled with a positive pressure vial with respect to ambient
pressure.
The one or more side ports (e.g., side port 1308) are located the
same distance from the point (e.g., point 1306) at a distal end of
the pencil point needle (e.g., needle 1300). The side ports are
located on the cylindrical part of the needle as close to the
tangent of the distal end (e.g., the point 1306) as possible.
The location and size of the side ports are selected to prevent
partial leaks. The side port of a selected pencil point needle is
located and/or sized of dimensions down the length of the needle so
as not to exceed the thinnest vial bung thickness. The selection of
the location and/or size of the side port further includes a margin
of minimum distance. The margin of minimum distance is the distance
where the minimum vial bung thickness (e.g., at the point of
penetration) exceeds the axial length of an individual side port
(or a set of side ports) by at least a predetermined margin.
Fluid transfer rates can be increased by penetrating a needle to a
depth within the pharmaceutical fluid container where more than one
set of apertures is in fluid communication with the interior of the
pharmaceutical fluid container (e.g., vial, IV bag). A puncture
motion trajectory inserts up to four sets of four apertures into
fluid communication with an interior of a vial. If the vial
contains sufficient fluid, then fluid is transferred from the vial
to a syringe through 16 apertures.
The APAS controller is programmed to monitor the volume of fluid
remaining in the vial (e.g., by determining the initial fluid
volume in the vial and the fluid volume added or withdrawn from the
vial). In response to determining the volume of fluid remaining in
the vial, the controller causes the APAS to perform operations to
control the insertion depth of a pencil point needle. The APAS
controls the penetration depth for fluid transfer operations so
that all of the sets of side ports that penetrate into the interior
of the vial are immersed in the fluid contained in the vial while
the fluid is being withdrawn from the vial. The penetration depth
of the needle within the vial is adjusted during a fluid transfer
operation such that selected sets of side ports remain immersed in
the fluid within the vial as the fluid level within the vial
changes.
Hole chamfering and or electro polishing prevents particulate
generation by the side ports. Experimental testing included three
hole and four hole side port designs. For example, the tested three
hole design had the holes spaced 120 degrees apart and the four
hole design had the holes spaced 90 degrees apart. Side ports are
fabricated using drilling, laser, electrical discharge machining
(EDM), grinding and/or water jet fabrication methods.
Experimental test results were obtained for the flow rate of a
typical open-ended hypodermic needle. Testing showed that the
average flow rate of a typical 18 gauge needle is 3.55 cubic
centimeters/second (cc/sec). By comparison, testing showed that the
average flow rate of a typical 16 gauge needle is 7.72 cc/sec.
Therefore, the flow rate difference between the 18 gauge needle and
the 16 gauge needle is 217%. The increased flow rate is attributed
to the increased inside diameter of the 16 gauge needle. Table 1
shows the nominal outer diameter (OD) dimensions, nominal inner
diameter (ID) dimensions and the nominal wall dimensions for a 16
gauge and an 18 gauge needle.
TABLE-US-00001 TABLE 1 Gauge Nominal OD Nominal ID Nominal wall 16
1.651 mm 1.194 mm 0.229 mm (0.0650 in.) (0.0470 in.) (0.0090 in.)
18 1.270 mm 0.838 mm 0.203 mm (0.0500 in.) (0.0330 in.) (0.0080
in.)
Experimental test results were also obtained for the flow rate of
pencil point needles with side ports that included three hole and
four hole side port pencil point needle designs. For example, each
side port had a diameter of 0.81 millimeters (mm) (0.032 inches).
The four hole side port needle design allowed a draw rate of 6.75
cc/sec of water and the three hole side port needle design allowed
a draw rate of 6.00 cc/sec of water. These draw rates are compared
to the flow rates of the typical 18 gauge and 16 gauge needles,
which are 3.55 cc/sec. and 7.72 cc/sec., respectively. In some
implementations, a 90 degree direction change of the fluid flow
and/or port restriction accounts for the slightly lower overall
flow rates compared to a typical 16 gauge needle.
In some implementations, a four hole side port needle is operated
at the three hole side port flow rate to allow for margin. The
margin may be beneficial in some applications that have the
potential for partial blockages of one or more of the side ports.
This allows for partial blockage of side ports without reducing the
fluid flow rate.
FIG. 14 is an illustration of an example narrow fluid channel on
the inside of a stopper 1400. FIG. 15 is an illustration of an
example of a marginal needle height. Partial blockages result from
the deformation of the stopper. The deformation of the stopper
(vial bung) results from the negative vial pressure causing stopper
concavity.
For example, a point at the distal tip of a pencil point needle is
shaped to have a small radius (a dull point) rather than being
ground to a sharp point. A pencil point needle that includes a dull
point is beneficial when taking into account the tolerance of the
needle and the positioning of a vial with respect to the
needle.
FIG. 16 is an illustration of an example misalignment of a needle
with a previous puncture hole 1600. If the needle and vial are not
substantially precisely aligned and there has already been a
puncture (e.g., previous puncture hole 1600) into the stopper
(e.g., a rubber stopper or vial bung) of the vial from a previous
operation, then the dull point of the needle will push up on the
stopper slightly in a subsequent puncture into the stopper. The
push up of the dull point of the needle on the stopper deforms the
rubber and makes the previous puncture hole available to the
needle. Therefore, the same puncture hole is found and reused with
substantially no cutting of the stopper or particulate generation.
In comparison to a needle with a sharp point, a needle with a dull
point generally requires a higher insertion force on the previous
puncture hole in order to reuse the previous puncture hole.
The degree of dullness of the point of the needle is a measure of
the radius of the point. For example, typical point radii are
0.00254 mm to 0.254 mm (0.0001 inches to 0.01 inches) but could
extend to a hemispherical point. Additionally, there is a practical
limit to the dullness of the point. At a certain measured dullness
the point of the needle may not cut a path through the stopper on a
first puncture. The point of the needle may instead push a plug or
core through the stopper creating undesirable particulate and a
large leak pathway. For example, suitable point radii for a 16
gauge needle includes radii in the range from 0.0254 mm to 0.381 mm
(0.001 inches to 0.015 inches).
A needle with a sharp point achieves a low insertion force, which
substantially reduces or eliminates any need for lubrication. The
points of some needles are sufficiently sharp and tend to create a
new puncture hole in a stopper if the point of the needle is not
substantially precisely aligned with a previous puncture hole. The
generation of additional new puncture holes in the stopper results
in the increased likelihood of coring, particle generation and
leaks.
In addition to the shape of the point of the needle, the
penetration or plunge velocity on the needle into the stopper plays
a role in allowing an offset or slightly misaligned needle to go
through a previous puncture path and hole. If the plunge velocity
of the needle is too high and the needle is misaligned with respect
to the stopper, the needle creates a new puncture hole in the
stopper. Creating new puncture holes in close proximity to previous
puncture holes elevates the chances of particle generation.
Reduction of the needle engagement speed reduces point cutting of
the stopper and generation of particulate. Experiments using
engagement speeds in the range of 300 mm/sec to 30 mm/sec indicate
that engagement speeds below 30 mm/sec, down to 1 mm/sec and below,
can preserve vial bung integrity. Slower engagement speeds allow
the point of the needle time to locate a previous puncture hole. In
order to achieve this alignment, suitable practical operating
engagement speeds are in the range of 5 mm/sec to 1 mm/sec.
Disengagement speeds may affect leakage during disengagement but
are not a major factor in determining bung integrity.
The shape of the point of the needle contributes to the success of
the pencil point needle finding a previous puncture hole.
Experiments suggest that, in general, the blunter the cone (the
point of the needle), the more likely the needle will be able to
find a previous puncture hole. However, a needle that has a long,
tapered point performs a first puncture through a vial bung using
lower insertion forces than a needle with a blunter cone.
FIG. 17 is an illustration of an example needle 1700 with a long
point 1702. The length of the tip of the needle is a factor when
engaging medical containers such as IV bags. If the tip of the
needle is too long, side punctures of the container occur depending
on how the container is held during the engagement of the needle
into the container.
FIG. 18 is an illustration of an example needle 1800 with a short
point 1802. For example, needle diameter to needle point length
ratios of 3:1 to 1:3 occur. Typical examples of needle diameter to
needle point length ratios are a 0.1651 mm (0.065 inch) diameter to
0.3048 mm (0.120 inch) tip length or a 0.1651 mm (0.065 inch)
diameter to 0.1778 mm (0.070 inch) tip length.
Lubrication is an additional factor that enables the needle to
follow a previous puncture path to engage in a previous puncture
hole. Lubrication reduces the friction between the needle point and
the seal member (the stopper or vial bung) material (e.g., rubber)
making the previous puncture path easier to follow. The composition
of the lubricant used is consistent with the composition of the
lubricant used on typical sterile needle. Lubrication and the
selection of the shape of the point of the needle enables the user
the option to increase the gauge of the needle used in the APAS
without incurring any damage to the stopper of a vial.
The repeated precise placement of the needles of multiple syringes
into the bungs of multiple vials can be problematic, especially
when a vial is placed in storage between fluid transfer operations.
Tolerances associated with the items (e.g., containers, vials,
syringes) and the equipment handling those items (e.g., syringe
manipulators, robotic manipulators) impedes absolute precision.
Some misalignment (which may be referred to herein as "wander")
occurs between the needle and the existing puncture hole in a
stopper. To minimize needle wander, a syringe manipulator device
includes positive alignment of the needle with needle gripper
fingers. The syringe manipulator device includes substantially
precise registration of the vial top by directly gripping the vial
at the top of the vial. Additionally, the APAS includes a bevel
orientation device to index the needle bevel.
In an experiment, a needle wander width of 0.25 mm (0.01 inches)
was measured using an 18 gauge blunt fill needle made by BD. Using
the 18 gauge blunt fill needle made by BD that exhibited a needle
wander width of 0.25 mm (0.01 inches), additional experiments
showed that some stoppers produced particulate, backside coring,
and leaks within eight to nine punctures.
For comparison, an experiment was performed using a 16 gauge pencil
point needle. In the experiment, the APAS performed positive
alignment of the needle with the needle gripper fingers. The APAS
also performed precise registration of the vial top by directly
gripping the vial at the top of the vial. However, the APAS did not
use the bevel orientation device. In the experiment, 50 hole
punctures were performed through the stopper. Observation of the
stopper indicated the appearance of a single puncture hole.
Continuing with the experiment, the same stopper was reset and
shimmed to induce a total needle wander width of 0.45 mm (0.18
inches). The APAS performed 40 additional hole punctures, ten in
each quadrant of the stopper. After a total of 90 punctures into a
worst case stopper both the outer and inner puncture holes appeared
as a single puncture hole. Additionally, the stopper exhibited
little or no evidence of particulate or cutting. This experiment
demonstrated that the pencil point needle followed the original
puncture hole each time a puncture was performed, despite the
induced offset to simulate wander.
In accordance with the above-described apparatus and related
methods, an example process for providing a needle puncture of a
medical container in a robotic cell includes repeatable alignment
and positioning of a pencil point needle, and may further include
controlled penetration speeds and depths based on seal
thickness.
FIGS. 19A-19B show a needle puncture into a stopper on a vial prior
to needle entry into the vial. FIGS. 20A-20B show a needle puncture
into a stopper on a vial after needle entry into the vial. FIG. 19A
shows a 16 gauge needle 1900 ready for injection (ready to puncture
a hole in stopper 2002). FIG. 19B shows the shape of the typical
deformation of the stopper 1902 during the first puncture of the
needle 1900 into the stopper 1902. FIG. 20A shows the shape of the
stopper 1902 after the needle 1900 breaks through the stopper
(creates a puncture hole through the stopper 1902). As shown in
FIG. 20A, the stopper "snaps" back into its original shape (the
position of the stopper 1902 in FIG. 19A). The fast action of the
stopper snapping back to its original shape allows for the quick
passing of the one or more side ports (e.g., side port 2004) though
the rubber minimizing the opportunity for leaks. FIG. 20B shows the
needle 1900 retracted in order to draw fluid from the vial.
However, due to the increased plunge depth required to ensure
needle penetration, the needle is retracted to bring the one or
more side ports (e.g., side port 2004) in substantially close
proximity to the inside surface of the stopper in order to draw all
of the fluid from the vial.
FIGS. 21A-21L are illustrations of example pencil point needles
that are used in an APAS. FIG. 21A is an illustration of a
proto-type 1, 16 gauge needle. FIG. 21B is an illustration of a
proto-type 12, 16 gauge needle. FIG. 21C is an illustration of a
proto-type 11, 16 gauge needle. FIG. 21D is an illustration of a
proto-type 10, 16 gauge needle. FIG. 21E is an illustration of a
proto-type 9, 16 gauge needle. FIG. 21F is an illustration of a
proto-type 8, 16 gauge needle. FIG. 21G is an illustration of a
proto-type 7, 16 gauge needle. FIG. 21H is an illustration of a
proto-type 6, 16 gauge needle. FIG. 21I is an illustration of a
proto-type 5, 16 gauge needle. FIG. 21J is an illustration of a
proto-type 4, 16 gauge needle. FIG. 21K is an illustration of a
proto-type 3, 16 gauge needle. FIG. 21L is an illustration of a
proto-type 2, 16 gauge needle. FIG. 22 is an illustration showing
example pencil point needles 2202, 2204, 2206, 2208 attached to
syringe barrels 2210, 2212, 2214, 2216, respectively, where the
pencil point needles 2202, 2204, 2206, 2208 include side ports.
FIG. 23A is an illustration of an example vial bung 2300 (stopper)
that is used in implementations and embodiments described herein.
The vial bung 2300 includes a rubber stopper body 2302, a top part
2304, a flange part 2306, legs 2308a, 2308b and laminated layer
2310.
FIG. 23B is an illustration of an example vial 2320 with a bung
2322 and a vial seal 2324. The vial seal 2324 maintains the bung
2322 in place in the vial 2320.
FIG. 23C is an illustration of an example vial 2340 with a bung
2342 sealed to the vial 2340 with a vial seal 2344. FIG. 23C also
shows an example needle 2346 that has punctured the bung 2342 where
the vial 2340 and the needle 2346 are co-aligned. The engagement
movement for the needle 2346 into the vial 2340 is along the
co-aligned axis (e.g., direction of motion is shown by arrow
2348).
FIG. 24 is an illustration of example syringe barrels 2460. A
syringe barrel includes a syringe tip. The syringe tip is secured
to the barrel of the syringe. Syringe tips can include, but are not
limited to, a luer lock tip 2462, a slip tip 2464, an eccentric tip
2466 and a catheter tip 2468.
FIGS. 25A-C are illustrations of example vial bungs. The vial bungs
are rubber stoppers with a wide range of rubber properties. As
shown in FIGS. 25A-C, the vial bungs include a wide range of
geometric features. The vial bungs are available in a wide range of
geometric shapes and sizes dependent, for example, on the size and
shape of the vial opening it will be placed into.
Vial bungs may have surface features (indents) that identify
puncture sites for the user. In some cases, the surface features
either locally increase or reduce the local entry angle of the
needle into the bung. An increase in the vial angle (e.g., vial
angle 1106) may provide additional entry angle margin.
The needle-syringe interface comprises a luer lock or other
suitable connection. For example, the needle-syringe interface
includes a slip tip onto which the needle slides without engaging
threads. To facilitate automated robotic handling, including needle
cap removal, the shape of the luer is configured such that an
opposed gripper clamps onto the luer and rotates to unscrew and
remove the needle. The needle cap is made so the needle is
protected and the cap is rigid enough for an opposed gripper to
grip it without squeezing it onto the enclosed needle.
In some implementations, an example system (e.g., an APAS) performs
a number of draws from a container such as a vial by using a
pattern of insertions distributed among various aperture locations.
In some example modes, a pattern includes controlling some needle
insertions to use previously created apertures. The example mode is
further controlled so that any one of a set of apertures receives
no more than one more insertion than any other aperture in the set
of apertures. In some other modes, the pattern includes creating up
to a predetermined number, density, or arrangement of substantially
separated apertures without using any previously created apertures.
In one example application, an example system makes a first
sequence of cannula and/or needle insertions into a fluid transfer
port using a first mode in which each aperture is substantially
spaced apart from previously created apertures, and then makes a
subsequent sequence of cannula and/or needle insertions using a
second mode in which insertions are substantially evenly
distributed among existing apertures.
In some examples, more than one size, shape, or type of needle or
cannula is inserted into a particular fluid port. In an example
system (e.g., an APAS), information about each needle or cannula is
tracked and associated with the orientation, location, and/or angle
of insertion into the fluid port. Such an example system selects a
most suitable pre-existing aperture for a proposed needle or
cannula to re-use.
In one example application, a system (e.g., an APAS) tracks and
controls the location, orientation, and type of apertures created
and the number of insertions in each aperture. The system obtains
fluid port characteristics, such as the usable area of the fluid
port, by recalling stored characteristic information from a
database, reading the characteristic information from a label, or,
for example, optical scanning (e.g., infrared, optical recognition)
to identify suitable regions for insertion. The system further
determines whether particular locations within the determined
suitable regions are suitable for inserting a particular needle or
cannula. The system further manages the location, orientation, and
number of insertions of each needle or cannula type, shape, or size
in each aperture.
The example system rejects a particular insertion for any of a
number of reasons. The system determines that a particular aperture
has been used a predetermined maximum number of times. The system
determines that a particular insertion would cause the
corresponding aperture to come too close (e.g., within a
predetermined keep-out region) of another planned or pre-existing
aperture. In some cases, the system determines the needle or
cannula to be of a different shape (e.g., radius of curvature,
bevel length), or size (e.g., diameter, thickness), which expands
the aperture more than a desired amount. If no suitable aperture is
determined to be available for the proposed needle, the system
rejects the requested needle insertion.
For example, the system (e.g., an APAS) determines that the fluid
port has apertures that have less than a specified maximum number
of insertions in at least one aperture, and/or the fluid port has
room available for receiving at least one more new aperture. Upon
determining that a suitable needle or cannula type is available,
the system automatically process the requested insertion using the
needle or cannula type determined to be suitable. In a particular
example, the system identifies a suitable inventory item, retrieves
the identified item, and orients the item to achieve the desired
aperture location and orientation upon insertion into the fluid
port. In some examples, the orientation is based on the stored
location, type, and orientation information about a pre-existing or
planned aperture in the fluid port.
If no suitable needle or cannula type is available, then the system
generates an appropriate electronic error message, which it then
saves in an electronic data store, and/or sends the message to
notify an operator. The system may further remove the container
with the exhausted fluid port from process inventory.
Queue Priority
An example of a batch mode of operation for an APAS is described
with reference to FIG. 18 of previously incorporated by reference
U.S. Pat. No. 7,610,115, entitled "Automated Pharmacy Admixture
System (APAS)," and filed by Rob et al. on Dec. 22, 2005.
FIG. 26 is a flow chart of an illustrative batch mode 2600 of
operation that is used to fill drug orders provided to the APAS.
The batch mode 2600 involves the loading of the inventory chamber
with a plurality items that include, but are limited to, input
drugs, diluents, syringes and IV bags for output doses to produce a
pre-defined set of drug orders. In an illustrative example, a
pre-defined set of drug orders are for a specific day. An operator
prepares a master daily prep list in step 2602, which is a list of
all the drug orders that the APAS needs to for the specific day.
The master daily prep list includes one or more prescriptions of a
particular type or one or more prescriptions of a variety of types.
The operator loads the master daily prep list, in whole or in part
(e.g., dependent on the size of the list), into the APAS as the run
list in step 2604
The APAS controller uses the run list to prepare the drug orders.
Software in the APAS screens the drug orders in the run list to
ensure that the APAS is trained to fill them. The APAS controller
identifies the inventory required to fill the drug orders and the
inventory rack configurations for the inventory from those
available. The APAS controller prepares a load list in step 2606 to
guide the operator through the loading of the inventory into the
inventory racks. The load list displays a list of racks into which
the inventory can be loaded, as well as a schematic diagram of each
rack. The inventory includes the drugs and diluents needed to
prepare the orders. For example, the inventory (the drugs and
diluents) is contained in vials, syringes, or IV bags.
Additionally, the inventory includes syringes (e.g., with needles
fitted) required for processing the orders and the output
containers for the drug doses. The output containers for the drug
orders include syringes or IV bags. For the case in which the
inventory required to fill a drug order is already on the inventory
racks, the identified inventory required is reduced or removed, and
the APAS utilizes the previously loaded inventory to prepare the
drug orders. For cases in which all the inventory required to fill
all drug orders is in the APAS, the steps 2608 and 2610 are
skipped. From the load list, the operator obtains stock from clean
room inventory in step 2606, and loads the inventory racks offline
in step 2610 with the stock in the positions on the inventory racks
as indicated by the load list.
The operator delivers the inventory racks to the inventory chamber.
The operator follows an inventory loading process as described in
FIG. 4, of previously incorporated by reference U.S. Pat. No.
7,610,115, entitled "Automated Pharmacy Admixture System (APAS),"
and filed by Rob et al. on Dec. 22, 2005. The operator unloads
empty inventory (or unused inventory) in step 2612 that may be in
inventory racks in the inventory carousels from a prior drug order
run. The operator unloads waste containers in step 2614. The
operator empties the waste containers in preparation for the
upcoming drug order run. The waste containers are contained below
the waste chutes 333, described in FIG. 3 of previously
incorporated by reference U.S. Pat. No. 7,610,115, entitled
"Automated Pharmacy Admixture System (APAS)," and filed by Rob et
al. on Dec. 22, 2005. The waste containers hold one or more empty
containers (e.g., used or empty syringes, bags, or vials) used by
the APAS.
Next, in the inventory loading process as described in FIG. 4 of
previously incorporated by reference U.S. Pat. No. 7,610,115,
entitled "Automated Pharmacy Admixture System (APAS)," and filed by
Rob et al. on Dec. 22, 2005, the operator loads the inventory racks
in step 2616 onto the inventory carousels. The operator begins the
batch process by setting the APAS to RUN in step 2618. The operator
selects the RUN button on a touch screen flat panel monitor 202 in
FIG. 2 of previously incorporated by reference U.S. Pat. No.
7,610,115, entitled "Automated Pharmacy Admixture System (APAS),"
and filed by Rob et al. on Dec. 22, 2005). The APAS runs
autonomously in step 2620, generating the output orders, which
depending on the drug container, are dropped into the syringe
discharge chute 332 or the IV bag discharge chute 344, which are
described with reference to FIG. 3 of previously incorporated by
reference U.S. Pat. No. 7,610,115, entitled "Automated Pharmacy
Admixture System (APAS)," and filed by Rob et al. on Dec. 22, 2005.
A receptacle disposed beneath each chute collects the output
containers. A pharmacy staff member takes the output away in step
2622 to be placed in inventory, for example, in a hospital
ward.
The APAS continues to run and prepare the batch drug orders until
the batch order run is complete in step 2624. The APAS generates a
signal to inform the operator of the completion of the batch order
run. The APAS informs the operator by displaying a message on a
flat panel monitor serving as the input/output device 306, which is
described with reference to FIG. 3 of previously incorporated by
reference U.S. Pat. No. 7,610,115, entitled "Automated Pharmacy
Admixture System (APAS)," and filed by Rob et al. on Dec. 22, 2005.
In some implementations, compounding operations cease if all
pending orders are complete, or if the inputs required to complete
any pending orders are not available on the inventory racks. In
other implementations, the APAS operates autonomously in a "lights
out" mode, substantially without operator intervention, to process
orders using available inventory.
Referring again to step 2604, the operator loads the master daily
prep list, in whole or in part (e.g., dependent on the size of the
list), into the APAS as the run list. For example, a user creates a
queue of orders via a graphical user interface displayed on a touch
screen flat panel monitor (e.g., monitor 202 in FIG. 2 of
previously incorporated by reference U.S. Pat. No. 7,610,115,
entitled "Automated Pharmacy Admixture System (APAS)," and filed by
Rob et al. on Dec. 22, 2005) or via a remote user station (e.g. RUS
206 in FIG. 2 of previously incorporated by reference U.S. Pat. No.
7,610,115, entitled "Automated Pharmacy Admixture System (APAS),"
and filed by Rob et al. on Dec. 22, 2005). The user adds a drug
order, multiple identical drug orders, or an intermediate bag order
as described in FIGS. 3-9. Drug orders are entered by specifying a
drug, a dose quantity, a dispensing item type (e.g., syringe or
bag), a drug concentration, a quantity and further dilution
diluent. Intermediate bag orders are entered by specifying a drug,
a diluent, a bag type and a quantity.
The APAS controller arranges multiple drug orders into a queue. In
some implementations, the user assigns the priority of the drug
orders in the queue. In other implementations, the priority of the
drug orders are determined by the APAS controller for optimization
purposes. The queue may be saved for future reuse, and identified
by its name.
Alternatively, to load a master daily prep list in the step 2604, a
user creates one or more patient specific drug orders on a file
transfer protocol (FTP) server. A user commands the APAS controller
to poll the FTP server for the drug order files. The APAS
controller organizes the orders into production queues, and the
user reviews and edits the queues, including moving orders from one
queue to another.
An example of an on-demand mode of operation for an APAS is
described with reference to FIG. 19 of previously incorporated by
reference U.S. Pat. No. 7,610,115, entitled "Automated Pharmacy
Admixture System (APAS)," and filed by Rob et al. on Dec. 22,
2005.
FIG. 27 is a flow chart of an on-demand mode 2700 of operation that
is used to fill orders provided to the APAS. The on-demand mode
2700 involves loading the inventory racks with a plurality items
that include, but are limited to, input drugs, diluents, syringes
and IV bags for output doses to produce drug orders that constitute
the most common drugs used on a given day. The APAS controller
prepares a load list in step 2702 to guide an operator through the
loading of the inventory into the inventory racks. A total set of
drug orders to be filled is captured from an order entry system or
manually entered by the operator. By analyzing the total set of
drug orders to be filled, the APAS controller determines an
aggregate number of drugs, syringes, vials and IV bags required to
fill the total set of drug orders. The remote user station provides
an aggregate list to the operator. The operator selects the drugs,
syringes, vials and IV bags required from current inventory to meet
the APAS load requirements for the total set of drug orders. The
inventory needed includes a complement of drugs and diluents, which
are contained in vials, syringes, or IV bags. Additionally, the
inventory needed includes an output container for the drug dose
(e.g., a syringe or IV bag). The operator enters the load list into
the APAS in step 2704 using, for example, the flat panel monitor
202 as described in FIG. 2 of previously incorporated by reference
U.S. Pat. No. 7,610,115, entitled "Automated Pharmacy Admixture
System (APAS)," and filed by Rob et al. on Dec. 22, 2005. From the
load list, the operator gets stock from clean room inventory in
step 2706. The operator loads the inventory racks offline in step
2708 with the stock in the positions on the inventory racks as
indicated by the load list.
The operator delivers the inventory racks to the APAS. The operator
then follows an inventory loading process as described in FIG. 4 of
previously incorporated by reference U.S. Pat. No. 7,610,115,
entitled "Automated Pharmacy Admixture System (APAS)," and filed by
Rob et al. on Dec. 22, 2005. The inventory process involves first
unloading empty inventory (or unused inventory) in step 2710 that
are included on the inventory carousels from the prior day's
operations. The operator unloads waste containers in step 2712 and
empties the waste containers in preparation for the day's orders.
The waste containers are below the waste chutes 333, described in
FIG. 3 of previously incorporated by reference U.S. Pat. No.
7,610,115, entitled "Automated Pharmacy Admixture System (APAS),"
and filed by Rob et al. on Dec. 22, 2005. The waste containers hold
empty containers used by the APAS. Next, in the inventory loading
process as described in FIG. 4 previously incorporated by reference
U.S. Pat. No. 7,610,115, entitled "Automated Pharmacy Admixture
System (APAS)," and filed by Rob et al. on Dec. 22, 2005, the
operator loads the inventory racks in step 2714 onto the inventory
carousels.
The APAS waits to receive drug orders, in step 2716. The APAS
receives drug orders from the hospital pharmacy by way of the
hospital network, as was described in FIG. 2 of previously
incorporated by reference U.S. Pat. No. 7,610,115, entitled
"Automated Pharmacy Admixture System (APAS)," and filed by Rob et
al. on Dec. 22, 2005. When the hospital pharmacy receives a drug
order, the hospital pharmacy enters the drug order into the APAS.
The APAS checks to make sure the supplies are in place to fill the
drug order in step 2718. If the supplies are available in step
2718, the APAS places the order in its queue in step 2720. The APAS
runs and completes the orders in step 2722. The output order,
dependent on the drug container, is dropped into the syringe
discharge chute 332 or the IV bag discharge chute 344, as described
in FIG. 3 of previously incorporated by reference U.S. Pat. No.
7,610,115, entitled "Automated Pharmacy Admixture System (APAS),"
and filed by Rob et al. on Dec. 22, 2005. A receptacle placed
beneath each chute collects the output container. A pharmacy staff
member takes the output away in step 2724 to be used that day, for
example, in a hospital ward.
If, when an order is received, the APAS determines, in step 2718,
that the supplies needed to fill the order are not in place, the
remote user station notifies the operator in step 2726. The
operator then proceeds to get stock from inventory in step 2706 and
begin reloading the APAS.
The APAS runs in either a batch mode or an on-demand mode dependent
on user needs. For example, the APAS runs in the on-demand mode
during the day shifts in a hospital, responding to demand from the
hospital as it arises. During the hospital evening and night
shifts, the APAS runs in the batch mode producing batches of drugs
that can be carried in bulk in the hospital pharmacy to maintain
inventory.
Table 2 below shows three example queues sorted according to
priority and sequence. In this example, the Floor 1 queue has the
highest priority, "Stat", and Floor 3 has the lowest priority,
"Low". Within each queue, orders are assigned a letter based on the
order that they are entered into an APAS, so OrderA is entered
first, OrderB second, etc. Each order is given a sequence number as
determined by the APAS controller. The orders are sorted within
each queue according to sequence number. In this example, if all
three queues were executed, OrderA would be executed first,
followed by OrderB, OrderC, OrderF, OrderD, etc.
TABLE-US-00002 TABLE 2 Floor 1: Stat Floor 2: Medium Floor 3: Low
Name Sequence Name Sequence Name Sequence OrderA 1 OrderF 3 OrderH
12 OrderB 2 OrderD 4 OrderI 33 OrderC 3 OrderE 7 OrderJ 21
Sorting of Drug Orders
An example of methods for drug order intake in an APAS are
described with reference to FIGS. 42, 43A and 43B of previously
incorporated by reference U.S. patent application Ser. No.
11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006.
FIG. 28 is a flow chart of an illustrative drug order processing
method 2800 for an APAS. The method 2800 begins with intake of a
drug order by the APAS in step 2805 from a hospital system. Various
methods for obtaining drug orders from the hospital system are
described with reference to FIGS. 42, 43A and 43B of previously
incorporated by reference U.S. patent application Ser. No.
11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006.
After completing the order intake in step 2805, the method 2800
parses and checks received drug orders in step 2810. When
individual drug orders are verified, the method 2800 adds the drug
orders to a production queue in step 2820. The addition of the drug
orders to the production queue are automatic or manual. An APAS
includes a plurality of queues. A user enters a series of drug
orders as a first queue, via a remote user station. Additionally, a
user commands the APAS to poll a FTP server for the drug order
files to create a second queue.
The drug orders are organized into queues according to the use of
the drug. For example, a queue is created for each prescribing
doctor or administering professional, or queues are grouped by
floor or medical wing of the patient to receive the drug. An
operator controls which queue a drug order is allocated to and may
move drug orders between queues. The production queue represents an
aggregate of orders to be released to the APAS for production. For
example, a first queue contains drugs to be administered to
patients on the ground floor of a hospital, and a second queue
contains drugs to be administered to patients on the second floor
of the hospital. If a patient is moved from the first floor to the
second floor, drug orders associated with that patient are moved
from the first queue to the second queue.
Each queue is pre-processed to determine the total aggregate of
drugs and consumables required to fill the drug orders in the
queue. The pre-determined total aggregate of drugs and consumables
required to fill the drug orders in the queue becomes the list of
inventory items for an operator to load into an APAS.
Whether the drug orders are to be released to the production cell
is determined in step 2825. If the drug orders are to be released
to the production cell, then the APAS performs the production of
the drug order in step 2830. If no drug orders are to be released,
then the method 2800 continues to an idle state in step 2835, after
which step 2805 is repeated.
The drug orders in each queue are sorted according to a priority
and sequence number. The drugs are sorted primarily according to
priority number, and sorted according to sequence number within the
priority number. In some implementations, priority numbers of 1-4
are used to represent priorities of Low, Medium, High, and Stat.
Within each priority number, sequence numbers used are the
identification number used by the APAS for the drug in the order,
drug concentration, and/or dose quantity. The user edits the
priority number of an order. Alternatively, the APAS controls the
priority number.
The APAS determines which queue to place a drug order in dependent
on the drugs and diluents needed to fill the drug order. For
example, the APAS places orders that use the same drug for
reconstitution in the same queue. This sorting of orders results in
increased performance as the APAS can reuse the same vial for
multiple drug orders.
Use of Planning Software and a Phantom Queue
FIG. 29 is an illustrative flow chart showing example operations
2948 for preprocessing a queue of drug orders. For example, the
process 2948 is performed after a queue of drug orders has been
received, and in preparation of procedures to fill the drug
orders.
The process 2948 begins with assigning dispensing items based on
dispensing profiles in step 2950. Dispensed syringes have
dispensing profiles, which specify the dose range (drug volume or
quantity) for a particular syringe size, fluid, and concentration.
In step 2952, buffer items are identified. An extra syringe of each
syringe type assigned in step 2952 are identified. The extra
syringe is used, for example, in the case where a syringe is found
to be defective or unusable.
Consumable items are identified in the step 2954. Syringes that are
used for intermediary transfers are identified. Diluents are mapped
to drug sources in step 2956, and drug sources are mapped to drug
orders in step 2958. With the steps 2956 and 2958, each drug order
has associated with it diluents and drug sources as needed.
Waste reduction planning is processed in step 2960. Techniques that
reduce waste or increase efficiency, such as safe reuse or serial
use of disposable items, are identified. Puncture limits of vials
and bags and other safety measurements are verified in the step
2962. Minimum and maximum values for each item are compared to the
associated planned values to ensure that each item is used within
the item's appropriate parameters. Pressure management is verified
in step 2964. The syringes requested for priming and the order of
draws are arranged from the same drug source from largest to
smallest volume. In step 2966, inaccessible and overfill volumes
are incorporated. Adjustments to the nominal value fluid sources
are applied to adjust for overfill or fluid that cannot be reliably
accessed.
Inventory is mapped to carousel positions in step 2968. The
carousel mapping is used by the APAS during processing to locate
inventory and is used by an operator loading the inventory before
processing. In step 2970, the APAS monitors inventory usage during
processing. Inventory needs can be modified during a failed process
or when an anomalous inventory item is discovered. When available,
inventory in the temporary storage is utilized in step 2972. For
example, if a particular vial is ruined during processing, a
duplicate of the vial in temporary storage can be used to continue
processing.
FIG. 30 is an illustrative flow chart showing example operations
3074 for inventory management and predictions. A phantom queue is
created to represent expected orders, and the phantom queue is
added to one or more real order queues to determine inventory to be
loaded into the APAS. The operations 3074 can be performed by a
processor that executes instructions stored in a computer-readable
medium. For example, a computer device operated by and included in
the APAS can perform the operations 3074.
The process 3074 begins with receiving historical orders in step
3076. The APAS controller accesses drug orders that have been
processed by the APAS, for example, in the previous month or week.
Orders, collections of orders, and/or queues that are regularly
processed in the historical orders are identified in step 3078. For
example, if a particular drug is ordered every day for the last
seven days, that drug order is identified. A phantom queue is
created in step 3080. The phantom queue contains the common orders
determined in the 3078. Additionally, an operator enters additional
orders to the phantom queue, for example, if the operator expects
an order in the near future.
In step 3082, orders are received. The received orders are
combined, and the inventory required to fill both the received
orders and the phantom orders is determined in step 3084. For
example, if the phantom queue consists of orders for two
intermediary bags and the received orders consist of orders for
three intermediary bags of the same drug, inventory requirements
are for five bags. The APAS outputs the inventory requirements. An
operator loads the inventory for both the received orders and the
phantom queue in step 3086. After loading, the APAS processes the
received orders that contain the inventory for the phantom queue.
Later, for example, if an order comes in that matches the orders of
the phantom queue, the later orders are processed without
additional loading of the APAS.
In one example, a particular patient staying at a hospital can
require the same dose of a particular drug administered every day
after dinner. The order for this drug is not received by the APAS
until noon, which is later than all other drug orders. In this
example, the APAS identifies the regular and late order, and
prepares a phantom queue before determining inventory requirements
for the day. After processing all morning orders, the APAS is still
loaded with the inventory to fill the noon regular and late
order.
Error Recovery and Exception Handling
FIG. 31 is an illustrative flow chart showing example operations
3100 for detecting and recovering from errors that may occur while
processing drug orders. The operations 3100 begin with the
processing of a queue of drug orders. While processing drug orders,
a number of possible errors are detected in step 3104 generating an
error event. The errors are logged in step 3106 based on the type
of error identified in steps 3110-3136. The log of errors is used,
for example, to detect a broken part in the APAS, to schedule
maintenance, and/or to determine calibration changes. In step 3110,
errors are identified that are corrected by repeating a failed
command. The APAS detects a plurality of errors that can include,
but is not limited to, the errors identified by the operations
3100.
In step 3112, deneedle and/or decapping errors are identified. A
syringe needle cap that is intended to be removed may not be
removed, or it may be detected that the syringe did not have a cap,
leading to the generation of an error event.
In step 3114, needle capping errors are identified. A camera
monitoring a needle cap can provide an image of the needle cap try
(e.g., using image processing techniques). The APAS, using the
provided image, detects that the intended cap to be used to cap a
syringe was not removed from the capping tray. The APAS determines
that needle capping did not occur, leading to the generation of an
error event.
In step 3116, needle bevel alignment errors are identified. The
APAS determines that the needle has an anomalous geometry
indicative of the wrong needle type or of particulate contamination
of the needle, leading to the generation of an error event.
Alternatively, the APAS determines that the syringe is not rotating
as intended during the bevel alignment process, leading to the
generation of an error event. Alternatively, the APAS determines
that the needle is not properly positioned or fully located within
a field of view of a camera on a bevel orientation device, leading
to the generation of an error event. FIGS. 4A-4C in previously
incorporated by reference U.S. patent application Ser. No.
11/937,846, entitled "Control of Fluid Transfer Operations," and
filed by Doherty et al. on Nov. 9, 2007 shows an example of a bevel
orientation device.
In step 3118, height errors are identified. The APAS determines
that the relative height of a vial drug source, an IV bag drug
source or diluent source, as held by the robot gripper fingers, is
not correct for handoff to the next subsystem, leading to the
generation of an error event.
In step 3120, port sanitization system (PSS) errors are identified.
Previously incorporated by reference U.S. patent application Ser.
No. 12/035,850, entitled "Ultraviolet Sanitization in Pharmacy
Environments," and filed by Reinhardt et al. on Feb. 22, 2008 shows
an example of a PSS. The APAS determines that a vial to be
sanitized is not fully engaged in the PSS interface, and thereby
does not draw an adequate vacuum to enable the PSS system, leading
to the generation of an error event. Alternatively, the APAS
determines that the PSS Ultraviolet (UV) source activation was not
operating continuously during the sanitization process, leading to
the generation of an error event. Alternatively, the APAS
determines that the current flowing to the PSS UV source is outside
of nominal limits and is not of the required intensity, leading to
the generation of an error event.
In step 3122, identification errors are identified. Identification
refers to identification of a source vial or IV bag as being the
correct item type. The APAS determines that the source vial or IV
bag barcode does not indicate the correct item type, leading to the
generation of an error event. Alternatively, the APAS determines
that the source item barcode cannot be read, leading to the
generation of an error event. Alternatively, the APAS determines
that the expected identifying pattern features for the source item
cannot be found, leading to the generation of an error event.
In step 3124, weight errors are identified. The APAS determines
that the weight of a source vial or IV bag is not within the
expected limits for that item, leading to the generation of an
error event.
In step 3126, diameter errors are identified. The APAS determines
that either the diameter of a source vial or the diameter of an IV
bag injection port is outside of the allowed nominal range, leading
to the generation of an error event.
In step 3128, expiry errors are identified. The APAS determines
that the pharmacy-trained expiry time for a punctured drug vial in
the APAS is exceeded, leading to the drug not being used and to the
generation of an error event. The expiry time is tracked from the
time of first puncture of a bung on a drug vial or IV bag port of a
diluent source.
In step 3130, printer errors are identified. The APAS determines
that a printed label is not properly dispensed onto a printer
platen, leading to the generation of an error event. Alternatively,
the APAS determines that a label failed to be picked up by the item
for labeling (e.g., a syringe or IV bag) during a labeling
operation, leading to the generation of an error event.
In step 3132, output chute errors are identified. The APAS
determines that a product has failed to drop out of the output
chute and into the output bins, leading to the generation of an
error event. The APAS prompts the operator to clear the output
chute. Alternatively, the APAS determines that an output chute door
(e.g., exterior door 3420, interior door 3415 as shown in FIG. 34)
fails to open or close, leading to the generation of an error
event.
In step 3134, label barcode errors are identified. The APAS
determines that the barcode on an output product cannot be scanned,
leading to the generator of an error event.
In step 3136, bin, bottle, and floor errors are identified. The
APAS determines that a waste bin sensor indicates "full", leading
to the generation of an error condition. Alternatively, the APAS
determines that a waste bin sensor indicates that a waste bin is
not installed, leading to the generation of an error event. Waste
bins are further described with reference to FIG. 33A-33B.
In steps 3138-3142, the process 3100 recovers from errors. Items
that have been completed correctly are salvaged in step 3138.
Completed drug vials are output, and/or unused syringes are
returned to available inventory or temporary inventory stock.
Failed, contaminated, corrupt, or otherwise unsalvageable items are
output as rejects in step 3140. A vial that has not been processed
is output from the APAS as a reject to be disposed of or reclaimed.
Active items are discarded in step 3142. For example, an IV bag,
which ruptures during processing in the APAS, is disposed of.
Additionally, the APAS can re-queue the one or more drug orders
that may be affected by the errors.
In one example, an APAS can process drug orders. The APAS attempts
to cap a syringe and fails. A capping error is detected and the
error is logged in a log file. The syringe is discarded, and the
order that required the capped syringe is repeated.
Inaccessible Volume Draw and Actual Volume Calculations
FIG. 32 is an illustrative flow chart showing example operations
3200 for drawing a volume of fluid from a fluid source, such as a
reconstituted or non-reconstituted drug vial, diluent bag, and/or
an intermediary bag. In some implementations, fluid sources handled
by the APAS have a nominal volume measurement assigned. The nominal
volume measurement is a large round number, such as 100 milliliters
(mL). However, the actual volume of fluid is, in some cases,
greater than or lesser than the nominal value, such as 103 mL or 97
mL of fluid in a nominal 100 mL vial.
For some fluid sources, attempts by the APAS to draw the entire
nominal or actual volume of fluid results in inconsistent draws.
For example, in some fluid bags, creases form and entrapped air is
drawn. In another example, for some vials, fluid wicks to the upper
lip of a vial bung. Some techniques, such as slurping while
withdrawing the needle from a vial, help to eliminate some of the
inconsistencies. Adjusting the draw value of each fluid source
allows for an increase in the available volume for some containers,
and for reliable draws from some containers.
The process 3200 executes to adjust the draw associated with each
fluid source. A nominal volume for a fluid source is entered into
the APAS in step 3202. When a drug vial is used for the first time,
or when an intermediary bag is planned, a nominal volume can be
given. The actual volume of the fluid source is compared to the
nominal volume in step 3204. Some fluid sources have an actual
value published by the manufacturer to ensure that, at a minimum,
the nominal volume is met in every order. Alternatively, an APAS
operator may discover that a fluid source runs out before the
entire nominal volume is drawn and the operator may estimate or
calculate the actual volume. If the actual volume is greater than
the nominal volume, a volume increase is received in step 3206.
Similarly, if the actual volume is less than the nominal volume, a
volume decrease is received in step 3208. The actual volume of the
fluid source is set in the APAS in step 3210 by adding the volume
increase or subtracting the volume decrease from the nominal value.
This actual value is stored and associated with every fluid source
of the same type processed by the APAS.
Through trial and error, experience with similar fluid sources, or
based on the design of the fluid source, the APAS operator
determines in step 3212 that some of the fluid in the fluid source
cannot be drawn reliably. The APAS operator enters an inaccessible
volume decrease in step 3214. The inaccessible volume decrease is
subtracted, by the APAS controller, from the actual volume in the
fluid source to determine a draw value in step 3216. The draw value
is the maximum volume that the APAS will draw from the fluid source
under normal operations. For example, the draw value is the volume
of liquid that can be reliably drawn from the fluid source.
The APAS trains the draw value for the fluid source in step 3218.
When processing the fluid source after training, the APAS draws up
to the draw value of fluid from the fluid source in step 3220.
For example, a reconstituted vial is given a nominal volume of 100
mL. It is found that, when properly reconstituted, the vial
contains 103 mL of fluid. Furthermore, it is found that 101 mL of
the 103 mL can be reliably drawn by the APAS. In this case, a
nominal volume adjustment of +one mL is trained into the APAS, for
a final available volume of 101 mL.
In another example, it is found that a vial of non-reconstituted
drug has a nominal volume of 100 mL and an actual volume of 101 mL.
It is determined that 98 mL is considered accessible by the APAS.
In this case, a total volume adjustment of -two mL can be trained
for that vial.
Multiple Separate Waste Bins
An example of a waste bin area included in an APAS is described
with reference to FIGS. 39A and 39B of previously incorporated by
reference U.S. patent application Ser. No. 11/389,995, entitled
"Automated Pharmacy Admixture System," and filed by Eliuk et al. on
Mar. 27, 2006.
FIGS. 33A and 33B show an illustrative waste bin area 3300 of an
APAS. The waste bin area includes one or more waste bins (e.g.,
waste bins 3305 and 3310), an interior door 3315, an exterior door
3320 and a waste bin area enclosure liner 3325. The waste bin area
3300 is coupled to the compounding area 3305 via a pass-through so
that the waste bins 3305, 3310 can be emptied without interrupting
cell processing.
The waste bin area 3300 includes a stainless enclosure 3330 that is
sealed from the ambient environment. The stainless enclosure
includes an enclosure liner 3325. The waste bin area 3300 is fitted
with the interior door 3315 that, when closed, isolates the waste
bin area 3300 from the compounding area 3305. The waste bin area
3300 is also fitted with the external door 3320. For example, an
operator accesses the waste bin area 3300 from the exterior for
removal of the waste bins 3305, 3310.
The interior door 3315 and the exterior door 3320 are interlocked
so that as the exterior door 3320 is opened a few degrees, the
interior door 3315 closes completely. As described with reference
to FIGS. 31A and 31B of previously incorporated by reference U.S.
patent application Ser. No. 11/389,995, entitled "Automated
Pharmacy Admixture System," and filed by Eliuk et al. on Mar. 27,
2006, a waste bin has a connection to the peripheral duct 3150
around the base of the APAS that causes air to be pulled from the
APAS into the waste bin area as long as the internal door 3315 is
open, and draws air from the exterior when the internal door 3315
is closed and the external door 3320 is open. For example, this may
substantially prevent aerosolized drug from the waste bin area 3300
from returning to the APAS area or escaping from the APAS. The APAS
performs the interlocking function with the use of a mechanical
linkage. Alternatively, the APAS performs the interlocking function
with the use of an electro-mechanical actuator on the internal door
3315, that includes sensing or operator switches on the external
door 3320 to initiate the actuator.
The APAS confirms the presence of waste bins 3305, 3310. The APAS
includes sensors located in the enclosure 3330 that detect the
presence of waste bins 3305, 3310. The remote user station warns an
operator if one or more of the waste bins 3305, 3310 are missing
prior to the start of a compounding operation.
Waste bins 3305, 3310 each include a waste-level sensor. The
waste-level sensor detects the level of waste in the waste bin
(e.g., waste bins 3305, 3310). The remote user station warns an
operator when the waste level in the bin is approaching the full
level. The operator halts the operation of the APAS during a
compounding operation, at a convenient time, to empty the waste
bin. Additionally, the waste-level sensor causes the APAS to halt a
compounding operation if the waste bin has reached the full level
and the waste bin needs immediate emptying.
The waste bins 3305, 3310 are a combination of standard medical
waste disposal containers. The waste bins 3305, 3310 are standard
sharps containers. Alternatively, the waste bins 3305, 3310 are
medical waste disposal containers specifically designed for the
disposal of cytotoxic waste.
Solid waste includes, but is not limited to: empty, partially used
or time expired diluent bags; empty, partially used or time expired
vials; used syringes with and without attached needles; failed dose
syringes that include attached, uncapped needles where the APAS was
unable to remove the needle, cap the needle, or label the syringe
for later reclamation by an operator by way of a reject rack; and
syringe cap trays which may be empty or which may include unused
syringe caps.
Additionally, the APAS includes a waste container inside the
compounding area for the disposal of needle caps and needles
removed from syringes during compounding. An example of the waste
container is waste receptacle 2335 as shown in FIG. 23 of
previously incorporated by reference U.S. patent application Ser.
No. 11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006.
An operator removes the waste bins 3305, 3310 from the APAS in
order to empty the waste bins. The operator empties the contents of
each of the waste bins into one or more larger waste containers
that accept the waste included in the bin. The larger waste
containers are located outside of the APAS. The operator reloads
the waste bins 3305, 3310 into the APAS for subsequent reuse.
In some implementations, a waste bin (e.g., waste bins 3305, 3310)
is designed to accept a sealing lid. An operator can store the
sealing lid inside the waste bin area 3300. The operator has
immediate access to the lid in order to apply the lid to the waste
bin before removal of the waste bin from the waste bin area. The
operator can empty the contents of the close-lidded waste bin into
a larger waste container outside of the APAS. Once emptied, the
operator removes the lid from the waste bin and places both the lid
and the waste bin back into the waste bin area 100 for subsequent
reuse. The close-lidded waste bin remains outside of the APAS for
later disposal. The operator loads the waste container area 3300
with a different lid and waste bin.
In some implementations, the waste bin area 3300 includes waste
bins 3305, 3310 for solid waste and an additional fluid waste bin
(container) for liquid waste disposal from the APAS. FIG. 7 shows
waste bins 702, 704 and liquid waste container 700. As described
with reference to FIGS. 6 and FIG. 7, the APAS uses an extraction
syringe and needle (e.g., syringe 604 and needle 606) to dispense
discarded liquid into a liquid waste drain tube (e.g., liquid waste
drain tube 602) located on the syringe manipulator device (e.g.,
syringe manipulator device 600). The liquid waste drain tube 602
drains the discarded fluid into the liquid waste container 700
located in the waste bin area of the APAS. A user may regularly
empty the liquid waste container 700 during APAS idle times.
During a compounding operation, the APAS discards fluid drawn into
a syringe from a container. The APAS discards fluid drawn into a
syringe during IV bag priming where an indeterminate amount of
fluid is drawn into the syringe. The APAS discards fluid from a
syringe while equalizing pressure in a container. The APAS discards
fluid drawn into a syringe where the fluid draw adjusted the amount
of diluent in the preparation of a final volume for an IV bag.
Referring to FIG. 4 and paragraph [0083] of the previously
incorporated by reference U.S. patent application Ser. No.
12/271,828, entitled "Method And Apparatus For Automated Fluid
Transfer Operations," and filed by Eliuk et al. on Nov. 14, 2008, a
syringe expels fluid previously drawn into a syringe into a drip
catcher. A syringe manipulator device includes a drip catcher. A
syringe manipulator device in an APAS is described with reference
to FIG. 7 of previously incorporated by reference U.S. patent
application Ser. No. 11/937,846, entitled "Control of Fluid
Transfer Operations," and filed by Doherty et al. on Nov. 9,
2007.
The fluid waste bin accepts fluid waste from the drip catcher
included in the syringe manipulation device. The APAS uses gravity
to assist drip catching from the drip catcher and into the fluid
waste bin. For example, a fluid waste bin having suction derived
from an exhaust fan in the APAS compounding cell assists the
gravity fed drip catching.
The APAS interacts with and monitors the fluid waste bin in a
similar manner as a solid waste bin. The APAS confirms the presence
of the fluid waste bin. The fluid waste bin includes a waste-level
sensor. The fluid waste bin is designed to accept a sealing
lid.
In some implementations, the APAS includes two or more solid waste
bins in order to segregate solid waste along with a liquid waste
bin. The APAS includes a first waste bin for glass containers
(e.g., vials), a second waste bin for plastic waste (e.g., IV bags)
and a third waste bin for sharps (e.g., syringes with needles
attached). Additionally, the APAS includes a fourth waste container
for liquids. Segregating solid waste may reduce the risk of
breakage of glass containers. Segregating solid waste separates
containers that may contain drug residue (e.g., glass vials that
contain a medicament) separately from containers that may contain
little or no drug residue (e.g., plastic IV bags that contain a
diluent). Segregating the sharps from the remaining solid waste
reduces if not eliminates the possibility of operator injury when
disposing of syringes with needles.
Monitoring of Output Chutes
An example of output chutes included in an APAS is described with
reference to FIGS. 35A-35C and FIGS. 36A-36B of previously
incorporated by reference U.S. patent application Ser. No.
11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006.
FIGS. 34A-34E show example views of a product output chute 3400 in
an APAS. A robot places products leaving the APAS in the product
output chute 3400. The product output chute 3400 includes one or
more product passages (e.g., chutes 3405, 3410, 3402), an interior
door 3415, an exterior door 3420, an interior face 3425 and an
exterior face 3430. The product output chutes 3405, enable the
segregation of products (e.g., syringes, IV bags, etc.) leaving the
APAS. The chutes 3405, 3410, 3402 include vertical product passages
where one or more motor-actuated doors close off the ends of the
vertical product passages. The interior door 3415 covers both
product passages. The exterior door 3420 closes off both product
passages.
FIGS. 35A-35B show example views of a product output chute 3400 in
the course of releasing a product from an APAS. An interior door
(e.g., interior door 3415) on the product output chute is normally
closed (e.g., closed interior door 3505) while an exterior door
(e.g., exterior door 3420) is normally open (e.g., open exterior
door 3510). When a product is ready for release from the APAS, the
exterior door closes (e.g., closed exterior door 3515), the
interior door opens (e.g., opened interior door 3520) and the robot
places the product through the opened interior door 3520 into one
of the vertical product passages or chutes (e.g., chutes 3405,
3410, 3402). The robot then releases the product. The product drops
into the selected product chute. The dropped product comes to rest
on the closed exterior door 3515. The opened interior door 3520
closes (e.g., closed interior door 3505). Sometime later (e.g., one
or more seconds), the exterior door opens (e.g., opened exterior
door 3510) and gravity assists the product in exiting the product
output chute 3400. Additionally, one or more actuators located in
the product passages can dislodge products that may adhere to the
product passage walls. The exterior door 3515 then closes when the
APAS detects that the product has dropped from the output chute.
The air in the output chute is purged to be clean when the interior
door 3520 opens.
Referring to both FIGS. 34A-34E and FIGS. 35A-35B, actuator 3406
controls the opening and closing of the interior door 3415.
Actuator 3530 controls the opening and closing of the exterior door
3420. Each vertical product passage or chute has a separately
controllable interior door, exterior door, or both. The output
chute doors (interior door 3415, exterior door 3420) are operated
by actuators that include, but are not limited to, solenoids,
stepper motors, servo motors, pneumatics, ball screws, belt drives
and force multiplying mechanical linkages. The output chute doors
(interior door 3415, exterior door 3420) include sensors to
indicate the position of the output chute doors. Each door includes
one or more sensors to indicate the position of the door (e.g.,
opened or closed).
A sensor for an output chute door supplies a digital signal to the
APAS controller that indicates if the output chute door is open or
closed. The digital signal provided by the sensor is equal to a
logical "1" (or is at a high level) when the output chute door is
open. The digital signal provided by the sensor is equal to a
logical "0" (or is at a low level) when the output chute door is
closed.
A sensor for an output chute door supplies an analog signal to the
APAS controller that indicates if the output chute door is open,
closed or in a position somewhere in-between open and closed. The
analog signal provided by the sensor is equal to a maximum signal
output level (e.g., a high level) when the output chute door is
fully open. The analog signal provided by the sensor is equal to a
minimum signal output level (e.g., a low level) when the output
chute door is fully closed. Using feedback, the analog signal
provided by the sensor is at signal levels between the maximum and
minimum levels dependent on the position of the output chute door
between fully open and fully closed, respectively.
Referring to FIGS. 34A-34E, a bottom passage (bottom chute opening
3445) of the product passages (chutes 3405, 3410, 3402) includes a
monitoring device 3440a, 3440b mounted inside of a protective
shroud 3404 on the exterior of the APAS. The monitoring device
3440a, 3440b monitors the successful exit of products from the
APAS. Signals generated by the monitoring device 3440a, 3440b
indicate the passage of the product out of the bottom chute opening
3445.
In some implementations, the monitoring device 3440a, 3440b is a
high-density light curtain. As a product exits the APAS through
bottom chute opening 3445, the product passes through the
high-density light curtain. The signals generated by the
high-density light curtain follow the passage of the product
through the bottom chute opening 3445 and out of the APAS. A light
curtain includes a transmitter and a receiver (monitoring device
3440a and monitoring device 3440b, respectively). The transmitter
of a high-density light curtain projects a high-density array of
parallel infrared light beams to the receiver. The receiver of a
high-density light curtain includes of large number of
photoelectric cells. As a product passes through the bottom chute
opening 3445, the product breaks one or more of the beams between
the transmitter and the receiver. Therefore, the monitoring device
3440a, 3440b monitors the passing of a product through the bottom
chute opening 3445 and out of the APAS. If a product does not pass
through the bottom chute opening 3445 (it is stuck), one or more of
the beams between the transmitter and the receiver is broken,
indicating the presence of the product passing through the bottom
chute opening 3445.
FIG. 36 is an illustrative flow chart showing example operations
3600 for detecting the presence of a product in a product output
chute (e.g., product output chute 3400). The operations 3600 can be
performed by a processor that executes instructions stored in a
computer-readable medium. For example, a computer device operated
by and included in the APAS can perform the operations 3600.
The operations 3600 are described with reference to FIGS. 34A-34E.
The operations 3600 begin when the robotic arm is releasing the
product. In step 3602, the APAS opens the exterior door 3420. The
APAS waits a first predetermined time (e.g., time t1) in step 3604.
The predetermined time (e.g., time t1) is determined based on an
average time for a product to exit the APAS through the bottom
chute opening 3445. In step 3606, the APAS controller determines if
the product passed through the bottom chute opening 3445 by
checking the monitoring device 3440a, 3440b. The monitoring device
3440a, 3440b indicates the presence of the product during passage
through the bottom chute opening 3445. The monitoring device 3440a,
3440b indicates the product has cleared the bottom chute opening
3445 when the APAS controller attempts to reset the monitoring
device in step 3608. In step 3610, the APAS controller checks the
monitoring device 3440a, 3440b to see if the product remains in the
bottom chute opening 3445. If the monitoring device 3440a, 3440b
continues to detect the presence of the product in the bottom chute
opening 3445, the remote user station alerts an operator of the
obstruction in step 3620. The remote user station instructs the
operator to clear manually the bottom chute opening 3445 before
closing the exterior door 3420 (e.g., remove the product by hand
from the bottom chute opening 3445). Once the operator removes the
product, the operator indicates to the remote user station that
they have removed the product in step 3622, clearing the
obstruction.
Additionally, in step 3610, if the monitoring device 3440a, 3440b
does detect a product in the field of view of the monitoring device
3440A, 3440b, then the APAS controller closes the exterior door
3420 of the product output chute 3400, in step 3612.
Once the APAS controller closes the exterior door 3420 in step
3612, the APAS controller checks one or more output chute door
sensors, as described above, for the exterior door 3420 to verify
that the exterior door 3420 is fully closed and sealed. If the
output chute door sensors for the exterior door 3420 indicate that
either door is not fully closed and sealed, the remote user station
alerts an operator to the error in step 3618. The operator is
instructed to clear the blockage (e.g., the stuck product) and
provide an indication to the remote user station that the blockage
has been cleared (e.g., the product has been removed) which is
received by the APAS in step 3622. The APAS controller then
instructs the exterior door 3420 to close.
If the output chute door sensors for the exterior door 3420
indicate that the exterior door is fully closed and sealed, the
operations 3600 end. The remote user station indicates to an
operator the successful exiting of the product from the APAS. The
APAS will then be ready to release the next product.
In some implementations, the monitoring device 3440a, 3440b is
high-density light curtain that includes a feature to self
calibrate and self check its own functionality. If the light
curtain self check discovers an internal problem with the light
curtain, an alarm flag is raised and the APAS control software
using the remote user station alerts the operator of the
problem.
Cross Contamination Management
During a reconstitution process, the robotic arm transfers a
syringe between stations using one or more gripper devices. The
gripper devices include gripper fingers used to grasp and hold the
syringe while transferring it between stations. The gripper fingers
hold the syringe while the APAS performs a particular operation.
Examples of gripper devices and gripper fingers are described in
previously incorporated by reference U.S. patent application Ser.
No. 12/209,097, entitled "Gripper Device," and filed by Eliuk et
al. on Sep. 11, 2008.
Because a syringe may contain fluid, there is the possibility of
small drips on the end of a needle prior to deneedling (removal of
the needle from the syringe) or on a luer lock hub on the syringe
after deneedling due to the squeeze of gripper fingers on the
barrel of the syringe. FIG. 46 of previously incorporated by
reference U.S. patent application Ser. No. 11/389,995, entitled
"Automated Pharmacy Admixture System," and filed by Eliuk et al. on
Mar. 27, 2006 shows an example of a syringe for use in an APAS. The
robotic arm is programmed to identify and/or follow a motion
trajectory when carrying a syringe from station to station to
minimize the opportunity for cross contamination. The path in the
APAS to a syringe capping station from a needle removal station is
arranged so as not to pass over any other equipment to
substantially minimize the chance that any drops might fall on
other surfaces (e.g., unused syringe caps, other medical
containers, surfaces that contact medical containers). Any drips
from the syringe are arranged to drop onto a drip pan that can be
cleaned. Additionally, disposable drip mats may cover the drip pan.
FIG. 24 in previously incorporated by reference U.S. patent
application Ser. No. 11/389,995, entitled "Automated Pharmacy
Admixture System," and filed by Eliuk et al. on Mar. 27, 2006 shows
an example of a needle removal station. FIG. 59 in previously
incorporated by reference U.S. patent application Ser. No.
11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006 shows an example of a
syringe capping station.
A syringe cap tray includes a plurality of syringe caps for
placement on the luer of a syringe by the APAS. FIG. 57 of
previously incorporated by reference U.S. patent application Ser.
No. 11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006 shows an example of a
syringe cap tray. When the robotic arm in the APAS delivers an
uncapped syringe to the syringe capping station, the APAS software
controls the robotic arm so that the uncapped syringe does not pass
over any of the other syringe caps to prevent any chance of drip
cross contamination. The robotic arm selects available syringe caps
from the outer edges of the syringe cap tray, or via some path that
substantially avoids an approach to a syringe cap that passes over
any other syringe cap on the way.
The possibility of small drips from a syringe occurs with and
without a needle on the syringe. The APAS performs drip management
to prevent cross contamination for syringes with and without
needles. The possibility of small drips on the fluid transfer port
of an IV bag occurs when injecting fluid into or drawing fluid from
an IV bag. The APAS performs drip management to prevent cross
contamination when handling IV bags.
Gripper fingers can be programmed to have a particular grip force
to prevent fluid from being squeezed out of the syringe. The
programmed gripper finger forces are different dependent on the
size of the syringe and the action being performed. For example,
the grip force for the syringe capping operation is higher than the
grip force for the operation for picking up a syringe from a
syringe scale.
When syringes are transported by the robotic arm within the APAS,
the orientation of the syringe is selected so that the force of
gravity and the acceleration and deceleration forces of transport
acting on the fluid inside the syringe do not act to pull fluid
from the needle or luer end of the syringe. This may substantially
reduce or eliminate the occurrence of any drips from the needle
and/or luer end of the syringe.
A syringe manipulator device employs a slurp function for drip
management. FIGS. 6 and 7 in previously incorporated by reference
U.S. patent application Ser. No. 11/937,846, entitled "Control of
Fluid Transfer Operations," and filed by Doherty et al. on Nov. 9,
2007 show examples of a syringe manipulator device. The slurp
function draws fluid out of the needle and into the luer lock hub
of the syringe. With the fluid level contained substantially inside
the syringe, the net effects of the compression forces generated by
the gripper fingers, the force of gravity and the forces of
transport are less likely to generate or liberate a drip at the end
of the needle or luer lock hub.
The APAS manages drips using a drip catcher. A drip catcher is a
suction device that includes a catcher or tray that is available on
a syringe manipulator device where a syringe purges excess air,
fluid or drips into the catcher. A drip catcher is also described
with reference to FIGS. 33A and 33B. Syringes used to transfer
diluent to a specific vial are used for the vial and the source
diluent bag.
The APAS performs drip management to prevent cross contamination
when using IV bags. The APAS controls the position and monitors the
height of an IV bag port to control drips to prevent cross
contamination. Examples of the control and management of IV bags
are described in the previously incorporated by reference U.S.
patent application Ser. No. 11/389,995, entitled "Automated
Pharmacy Admixture System," and filed by Eliuk et al. on Mar. 27,
2006. The position of an IV bag port is tightly controlled in an
inventory rack. Additionally, the APAS performs a second check on
the position of the IV bag port by using a port height sensor
included in a syringe manipulator device, an example of which is
shown in FIG. 7 in previously incorporated by reference U.S. patent
application Ser. No. 11/937,846, entitled "Control of Fluid
Transfer Operations," and filed by Doherty et al. on Nov. 9, 2007.
By controlling and monitoring the height of the IV bag port, the
syringe manipulator device accurately controls the penetration of
the needle of a syringe into the IV bag port. Accurate monitoring
of the IV bag port height prevents the IV bag port from contacting
the needle gripper included on the syringe manipulator device.
The syringe manipulator device controls the penetration of the
needle of a syringe into the port of the IV bag. Slowly penetrating
the port of an IV bag with the needle of a syringe on the syringe
manipulator device enables the rubber portion of the IV bag port to
flow past the needle. Slow retraction of the port of the IV bag
from the needle prevents the creation of a vacuum or suction in the
neck of the IV bag preventing the needle from creating drips on
surfaces in the syringe manipulator device.
In some implementations, IV bag ports are covered or "taped" when
inside the APAS. The covered IV bag ports contain the injection
site and any fluid residue that may be present on the injection
site on the port of the IV bag.
Release of Labeled Items from Gripper Fingers
Gripper devices include gripper fingers used to grasp and hold a
vial while transferring it between stations in the APAS. The
robotic arm 218 shown in FIG. 2 further includes gripper fingers in
order to grasp, hold and transport a vial between stations in the
APAS 100. The gripper fingers hold the vial while the APAS performs
a particular operation. Examples of gripper devices and gripper
fingers are described in previously incorporated by reference U.S.
patent application Ser. No. 12/209,097, entitled "Gripper Device,"
and filed by Eliuk et al. on Sep. 11, 2008 and previously
incorporated by reference U.S. patent application Ser. No.
11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006.
A vial has an adhesive-backed label applied to the vial. The label
includes information regarding the medicament contained in the vial
(e.g., drug name, expiration date, bar code, etc.). FIG. 45 of
previously incorporated by reference U.S. patent application Ser.
No. 11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006 shows an example of a vial
that includes an adhesive-backed label. A robotic arm includes a
set of gripper fingers for grasping the vial. When the robotic arm
grasps a vial that includes an adhesive-backed label, a
self-centering process occurs that allows the gripper fingers to
grasp the vial substantially in the center of the label. When
grasping the vial with the gripper fingers, the gripper fingers of
the robotic arm may abraid the vial label. The abraiding of the
label by the gripper fingers of the robotic arm causes a portion of
the adhesive on the label to contact the gripper fingers. While
transporting the vial within the APAS, the robotic arm grasps the
vial at a first station and transports the vial to a second
station. When the robotic arm places the vial at the second
station, the gripper fingers open to release the vial, and the vial
may remain lightly stuck to one of the gripper fingers. As the
robotic arm retreats, the robotic arm may pull the vial along. This
causes the vial to tip over during an upward motion or fall from
the gripper fingers once the second station no longer provides
support for the vial.
To correct for the partial sticking of a vial label to the gripper
fingers upon release of the vial from the gripper fingers, when the
robotic arm places the vial at the second station, the gripper
fingers open less than a full open amount (e.g., approximately 1
mm). The robotic arm then moves down along the vial axis a distance
(e.g., a few millimeters) in order to unstick the vial label from
the gripper fingers (break any residual stiction between the
gripper fingers and the vial label). The gripper fingers then
continue to open to their full open amount. The robotic arm
retreats from the station leaving the vial behind for further
processing by the APAS.
Handling of IV Bag Differences
The APAS handles multiple sizes and brands of IV bags as described
in previously incorporated by reference U.S. patent application
Ser. No. 11/389,995, entitled "Automated Pharmacy Admixture
System," and filed by Eliuk et al. on Mar. 27, 2006. The APAS is
configured to use a specific brand or type of IV bag. Once
configured for a brand or type of IV bag, the APAS handles all
sizes of that brand or type of IV bag. In order for the APAS to
handle and process all sizes of a particular type or brand of IV
bag, the IV bag should exhibit consistent port geometry for the
port of the IV bag over the full range of IV bag sizes.
A plurality of stations and devices in the APAS include IV bag
specific interfaces in order to handle the plurality of IV bags
configured for use in the APAS. Referring to FIG. 2, the stations
and devices include, but are not limited to: robot gripper fingers
(previously incorporated by reference U.S. patent application Ser.
No. 11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006 shows examples of robot
gripper fingers); IV bag racks (e.g., racks 210 that can include IV
bags); an IV bag scale (e.g., scale station 226); a port
sanitization system (previously incorporated by reference U.S.
patent application Ser. No. 11/389,995, entitled "Automated
Pharmacy Admixture System," and filed by Eliuk et al. on Mar. 27,
2006 shows examples of port sanitization systems); a temporary bag
storage location (e.g., IV bag parking location 800); a syringe
manipulator device (e.g., needle-down syringe manipulator 234) and
a container compressor (previously incorporated by reference U.S.
patent application Ser. No. 12/271,828, entitled "Method And
Apparatus For Automated Fluid Transfer Operations," and filed by
Eliuk et al. on Nov. 14, 2008, shows examples of container
compressors).
The APAS switches from using one brand or type of IV bag to another
brand or type of IV bag with the use of a kit. A series of kits
allow the conversion of the APAS to an IV bag type compatible with
the needs of a particular customer or hospital.
In some implementations, the APAS uses an IV bag specific interface
for some but not all IV bags used in the port sanitization system.
The APAS uses a non-specific IV bag interface on a station or
device for labeling an IV bag (e.g., bag labeler tray station 242),
identifying an IV bag (e.g., output scanner station 230) and for
outputting an IV bag (e.g., IV bag discharge chute 244). The
non-specific bag interface may not require the use of a kit or
other specific hardware changes when reconfiguring the APAS for use
with a new brand or type of IV bag.
In some implementations, an operator places a clip or other type of
attachment onto the port of the IV bag or onto the entire IV bag or
a portion of the IV bag. The exterior of the attachments have
standard features that interface with the stations and devices
described. The clips allow the APAS to use different brands and
types of IV bags concurrently as long as the appropriate clip or
attachment is available to match the brand and type of IV bag.
The use of clips or attachments for IV bags that enable the APAS to
use a plurality of brands and types of IV bags concurrently is
convenient to design and implement. However, an operator has to
install manually the clips or attachments on each IV bag before
loading the IV bag onto the inventory racks. Additionally, the
operator may have to remove the clip or attachment from the IV bag
once the IV bag is dispensed from the APAS. Alternatively, the
robotic arm may remove the clip or attachment prior to dispensing
the IV bag from the APAS.
Additionally, the clips or attachments are sanitized prior to use,
between uses, or on a schedule (if they are reusable).
Alternatively, the attachments are disposable one-time use devices.
The customer may determine the use of a one-time use attachment
verses the use of a multi-use attachment based on cost (e.g., the
cost of using the attachment once verses the cost of cleaning and
reusing the attachment).
Printer Platen for Syringe Labeling
Referring to FIG. 2, the labeling station 228 includes one or more
printers for printing labels for output containers (e.g., syringes,
IV bags). The labeling station 228 interacts with the bag labeler
tray station 242 where a label printed by a printer included in the
labeling station is applied to an IV bag. FIGS. 37A-37B in
previously incorporated by reference U.S. patent application Ser.
No. 11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006 show an example of a printer
system for a labeling station (e.g., labeling station 228). FIG. 38
in previously incorporated by reference U.S. patent application
Ser. No. 11/389,995, entitled "Automated Pharmacy Admixture
System," and filed by Eliuk et al. on Mar. 27, 2006 shows an
example of a label tray that may be a syringe label tray or an IV
bag label tray.
FIGS. 37A-37B show an illustrative printer system 3700 for an APAS.
The printer system 3700 includes printers 3705, 3710 mounted in an
enclosure 3715 that includes an automated label shuttle 3735 that
provides a pass through into the compounding area. The printer
system 3700 includes a printer mounting plate 3775 that includes a
quick release pin 3770 that enables the easy removal of the printer
mounting plate 3775 assembly. The enclosure 3715 includes an
external door 3730 for an operator to access the printers 3705 and
3710 for loading media and servicing. The printer enclosure 3715 is
sealed against a panel 3765 that is located inside of the external
door 3730 and mounted to the doorframe. The panel 3765 seals the
inside of the APAS from the ambient environment when the operator
opens the external door 3730, for example, for printer
maintenance.
The APAS controller operates the printer enclosure 3715 at a more
negative pressure than the compounding area through a duct
providing fluid communication from the interior of the printer
housing to a low pressure point in the air handling system and/or
active fans. The negative relative pressure may substantially
reduce particulate generated by printer operations from migrating
from the printer enclosure 3715 into the compounding area. FIGS.
31A-31B in previously incorporated by reference U.S. patent
application Ser. No. 11/389,995, entitled "Automated Pharmacy
Admixture System," and filed by Eliuk et al. on Mar. 27, 2006 show
an air handling system in an APAS.
The printer system 3700 includes a set of spring-loaded printer
housing doors 3720 and 3725 that open into the enclosure 3715 to
receive label trays on the automated label shuttle 3735 from the
compounding area. The shuttle 3735 includes a slide motor 3740, a
slide cover 3745, a slide motor housing 3760, a bag label tray 3750
and a syringe label tray 3755. The shuttle 3735 pushes the
pass-through doors 3720 and 3725 open to enter and capture the
printed labels for presentation to a syringe or an IV bag for label
application.
FIG. 38 is an illustration of a printer platen 3800 (label tray)
for labeling syringes in a printer system (e.g., printer system
3700). The printer platen 3800 improves label application on
syringes, the placement of the label on the syringe and the
reliability of the initial label adhesion for transfer from the
printer platen 3800 to the syringe.
As described with reference to FIGS. 37A-37B, a separate printer
enclosure 3715 includes the printer system 3700. Housing printers
3705, 3710 in a separate enclosure 3715 prevents printer-generated
contamination of critical processes in the compounding area. The
printer platen 3800 is located adjacent to the printer enclosure
(e.g., labeling station 228 and bag labeler tray station 242).
FIG. 39 is an illustration of the printer platen 3800 for labeling
syringes in a printer system (e.g., printer system 3700) that shows
a label 3902. The label 3902 is shown with its adhesive side facing
up. Referring to FIGS. 38 and 39, the printer platen 3800 moves
into the printer enclosure 3715 where a printer feeds the label
3902 coming out of the printer onto the platen 3800 in the
direction shown by arrow 3816.
The label 3902 engages an end stop 3802 on the printer platen 3800
as the label 3902 is fed out of the printer and approaches a limit
of travel. A lateral actuator 3804, moving in the direction
indicated by arrow 3814, pushes the label 3902 against side stops
3806, 3808 that run along the side of the label 3902 to register
laterally the label 3902 (register the label 3902 from side to
side). However, the edges of the label 3902 should not contact the
side stops 3806, 3808 during label feed. The contact should not
occur because adhesive on the label 3902 may cause a label edge to
stick to anything it touches. Therefore, lateral label registration
can occur after the printer fully feeds the label 3902 out of the
printer.
To ensure the label 3902 remains registered in place on the printer
platen 3800 during movement of the printer platen 3800, a label
restraint finger 3810 pushes down on the adhesive side of the label
3902 to pinch the label 3902 in place on the printer platen 3800.
The pushing down of the restraint finger 3810 on the adhesive side
of the label 3902 ensures that any residual sticking of the label
3902 to backing paper that it was peeled from will not occur.
Additionally, the pushing down of the restraint finger 3810 on the
adhesive side of the label 3902 ensures that air currents in the
APAS cannot disturb the label 3902 on the printer platen 3800 as it
moves out of the printer enclosure 3715 for presentation to a
syringe.
After positioning and securing the label 3902 on the printer platen
3800, the printer platen 3800 moves out of the printer enclosure
3715 with the label 3902 affixed to the printer platen 3800,
bringing the label 3902 into the compounding area.
FIG. 40 is an illustration of the printer platen 3800 for labeling
syringes in a printer system (e.g., printer system 3700) that shows
a label 3902 and a syringe 4002 for labeling. For example, a
robotic arm that includes gripper fingers to hold a syringe
presents the syringe 4002 to the printer platen 3800. The robotic
arm presents the syringe 4002 with the axis of the syringe
perpendicular to the long dimension of the label 3902 and at the
mid point of the length along the long dimension of the label 3902,
and parallel to the plane of the label 3902. The syringe 4002
touches the surface of the label 3902 in order to stick the label
3902 to the syringe 4002 in an initial line of contact. The printer
platen 3800 includes a compliant area, in a compliant platen
section 3812, beneath the location on the printer platen 3800 where
the syringe 4002 pushes down on the label 3902. Additionally, the
syringe 4002 pushes down on the label 3902 to a level of
approximately one millimeter below the initial contact of the
syringe 4002 and the label adhesive.
The restraint finger 3810 and the lateral actuator 3804 are
released. The robotic arm pushes the syringe down by an additional
approximate four to five millimeters. The additional pushing down
of the syringe 4002 results in further deflection of the compliant
platen section 3812.
Improvement in the repeatability of the placement of the label 3902
on the printer platen 3800 by a label printer (e.g., printers 3705,
3710) improves the repeatability of the placement of the label 3902
on the syringe 4002. The use of the lateral actuator 3804 to
register laterally the label 3902, and the restraint finger 3810 to
secure the label in place until the syringe has initially contacted
the label 3902 improves label placement repeatability.
Additionally, the compliant platen section 3812 improves initial
contact and affixing of the label 3902 to the syringe 4002. The
lateral actuator 3804 registers the label 3902 in a repeatable
manner from side to side. The lateral actuator 3804 fully
constrains the label so that the presentation of the label 3902 to
the syringe 4002 is repeatable. An electronic device moves the
lateral actuator 3804. Alternatively, the printer platen 3800 uses
an electric solenoid to move the lateral actuator 3804.
The pressing down of the syringe 4002 by the robotic arm in the
compliant platen section 3812 improves the reliability of the
initial adhesion of the label 3902 to the syringe 4002. The use of
a rigid platen section enables the robotic arm holding a
nominal-diameter syringe to touch the syringe lightly to the
adhesive side of the label. In some cases, a
smaller-than-nominal-diameter syringe may fail to make contact with
the adhesive side of the label resulting in a label pickup failure.
In some cases, a larger-than-nominal-diameter syringe may fail to
make contact with the adhesive side of the label resulting in a
label pickup failure. The larger-than-nominal-diameter syringe may
erroneously contact the edge of the printer platen. This contact
may pitch up the syringe not allowing the syringe to make adequate
contact with the adhesive side of the label.
The incorporation of the compliant platen section 3812 in a printer
platen 3800 improves the syringe to label contact for all diameter
syringes. The compliant platen section 3812 is a spring actuated
rigid section in the printer platen 3800. Alternatively, the
compliant platen section 3812 is a thick foam pad, a pneumatic
cushion, or a pneumatic actuated rigid section.
Manual and Autonomous Robot Teaching of Interfaces
As described with reference to FIG. 2, the processing chamber 204
includes a multiple degree of freedom robotic arm (robot) 218. For
example, the robotic arm 218 includes gripper fingers that can pick
items from a pocket on an inventory rack or that can grasp items
within the APAS for manipulation. The robotic arm 218 responds to
command signals from a controller to pick up, manipulate, or
reposition inventory items within the processing chamber 204, and
in or around the carousels 210, 212.
FIG. 41 is an illustration of an example robot (robotic arm) 4100
that includes a Z pointer direct mounted teach tool 4102. The APAS
100 can use the robot 4100. In order to safely and reliably operate
the APAS, tight control of the robot 4100 and its interfaces and
the interfaces of any other moving and interacting components
within the APAS are required. In general, repeatability within the
domain of a robot coordinate system may be higher than the absolute
accuracy of the robot over its working sphere. Therefore, robots
are "taught" where interfaces are, and the robots then return to
the location of the taught interfaces with high accuracy.
Direct taught points in a local coordinate reference frame
represent the location of the interfaces. A series of three taught
points defines a reference frame for the robot 4100. The robot 4100
can work accurately within the referenced frame. The APAS
controller commands the robot 4100 to move to various features in
the APAS with known geometry. The APAS controller commands the
robot 4100 to move to computed or measured positions relative to
the robot 4100. The direct teaching of points within the reference
frame for the robot 4100 for critical interfaces improves the
accuracy of the robot 4100 within the APAS. In some
implementations, the series of taught points includes a number of
points more than or less than three.
Manual robot controls and manual measurements can be used for
teaching robot points. A robot flange 4104 is equipped with one or
more teach tools (e.g., teach tool 4102) mounted directly to a
robot flange interface.
FIG. 42 is an illustration of an example robot (robotic arm) 4200
that includes a straight pointer teach tool 4202. FIG. 43 is an
illustration of an example robot (robotic arm) 4300 that includes
an offset pointer teaching tool 4302. The robot flange 4104 is
equipped with a gripper. The gripper grasps the teach tool. FIG. 42
shows an example of a straight pointer teach tool 4202 held by a
robot gripper. FIG. 43 shows an example of an offset pointer teach
tool 4302 held by a robot gripper.
The relationship of the teach tool to the end of the robot is
geometric. The relationship of the teach tool to the end of the
robot is taught through direct measurement. The relationship of the
teach tool to the end of the robot is taught through measurements
and statistical techniques that are based on one or more fixed data
points in the APAS or on the robot.
In a manual teaching process, the operator manually guides the
robot to the taught reference point using a robot teach pendant and
the assistance of software controls. At the appropriate taught
reference point, the operator enters that "here" (the location
pointed to (touched) by the end of the robot (the teach tool)) is
where the taught reference point is. The taught reference point
(measurement data) can be saved in a robot controller.
Alternatively, the taught reference point is transferred manually
or autonomously to the APAS control computer. Alternatively, the
taught reference point is saved in both the robot controller and
the APAS control computer.
The process for teaching a reference frame is the same as the
process for teaching reference points. In the case of reference
frame teaching, the process uses three points as reference frame
points. The process calculates the reference frame and saves the
reference frame. Alternatively, the process saves the reference
frame as a series of reference points where the process calculates
the reference frame at run time.
Manual teaching can be slow, laborious and error prone and can
require a relatively high level of operator skill. Additionally,
manual teaching can require visual access to teach points, which
may be difficult to achieve. Additionally, manual teaching can
discourage routine teach point checking, which can be a significant
aid to reliable operation.
Autonomous teaching is used to teach robot points. The concept of
autonomous teaching is to equip the robot with the devices needed
to allow the robot itself to determine its own interface
relationships. This enables the robot to determine and update its
interface relationships with a minimum amount of manual setup and
intervention.
FIG. 44 is an illustration of an example robot (robotic arm) 4400
that includes a wielding touch probe teach tool 4402. The robot
utilizes an attached sensor in autonomous teaching. For example,
the sensor is an analog or digital sensor and operates by touch or
electro-optics. FIG. 44 shows an example wielding touch probe teach
tool 4402 that includes a sensor. The robot gripper grasps the
touch probe teach tool 4402 and uses it for teaching. The touch
probe teach tool 4402 is handed off by the operator for the robot
to grasp. The touch probe teach tool 4402 is picked up by the robot
autonomously in the APAS. The touch probe teach tool 4402 is
directly wired to the APAS or robot. Alternatively, the touch probe
teach tool 4402 operates wirelessly using, for example, an optical,
radio frequency (RF), or other type of wireless connection. The
robot 4400 picks up the touch probe teach tool 4402 with no change
in its operating configuration. This enables the robot 4400 to
transition to and from a teaching configuration quickly and with
minimal effort.
After the robot 4400 picks up the touch probe teach tool 4402, the
APAS performs a self-check operation on the touch probe teach tool
4402. The APAS re-teachs or verifies the touch probe teach tool
4402 relative to the robot mounting flange. The APAS performs the
verification using a fixed hard point that is invariant relative to
the robot and measured autonomously or re-taught with the touch
probe teach tool 4402.
FIG. 45 is an illustration of the touch probe teach tool 4402 in
the process of autonomous point teaching. The touch probe teach
tool 4402 finds, touches and teaches key points in the APAS. The
APAS teaches reference points directly in a nominal "world" frame
for the robot, or, in most cases, the APAS determines a reference
frame to use in interfacing to a subsystem or group of points in
the APAS.
In some implementations, the APAS uses techniques that allow the
touch probe teach tool 4402 to safely maneuver and feel its way
around the reference points to teach. In some cases, the reference
points may be considerably off nominal. For example, points in a
new APAS for initialization with a set of "nominal" initial points
will initially include points that are significantly off
nominal.
The APAS control software uses a plurality of algorithms to teach a
reference frame and reference points. The touch probe teach tool
4402 iteratively feels out each of the points associated with a
reference frame. The APAS control software renders the reference
frame and uses the reference frame for a second refinement of the
frame points. The APAS control software uses an algorithm that
involves determining two lines to find a plane. Taught points may
not be real corners or identifiable physical points. Taught points
are a combination of any surface ordinates that relate to the
reference frame in a repeatable way and form a "virtual" point.
The APAS uses a variety of touch probes as teaching tools where the
touch probes vary in sensitivity and accuracy. The APAS uses touch
probes with different touch probe end (staff) lengths and ball
sizes. The APAS uses a touch probe with a longer staff to increase
probe reach and sensitivity, however the touch probe with the
longer staff can reduce probe accuracy. The APAS may use a touch
probe with a shorter staff in order to increase probe accuracy.
The use of a touch probe for autonomous teaching in an APAS can be
beneficial. The APAS uses the touch probe on relatively flexible
structures (e.g., syringe scale station 226 in FIG. 2) that may be
difficult to reach and teach. The APAS controller uses different
robot motion speeds for a teaching process. For example, slower
robot speeds may increase accuracy. The APAS controller may use
higher robot speeds in order to save time.
Typical touch probe repeatability can be in the range of one
micrometer. The APAS uses touch probes whose repeatability can be
one, ten or one hundred micrometers. One or more interface
relationships between the robot and a subsystem in the APAS
requires teaching to the order of 100 micrometers, which is within
the repeatability of the touch probe. Additional interface
relationships between the robot and a subsystem in the APAS may be
less critical and require teaching to the order of 200
micrometers.
The APAS uses the robot 4400 with the touch probe teach tool 4402
to enable the robot itself to determine and update its interface
relationships. Additionally, the APAS uses the robot 4400 with the
touch probe teach tool 4402 in a local reference frame as a
measuring device to teach interface relationships between other
items in the APAS. In some implementations, the robot 4400 with the
touch probe teach tool 4402 is a coordinate-measuring machine (CMM)
device that measures the physical geometrical characteristics of an
object. For example, the robot 4400 with the touch probe teach tool
4402 teaches the height relationship of the vial fingers on the
syringe manipulator device to the vial scale platen. The APAS uses
this relationship to control the robot when dropping off a vial on
the vial scale platen. In another example, the robot 4400 with the
touch probe teach tool 4402 teaches the dimensions on the syringe
manipulator device between the syringe needle gripper and the
syringe plunger gripper at a known position for needle tip control.
FIG. 52A in previously incorporated by reference U.S. patent
application Ser. No. 11/389,995, entitled "Automated Pharmacy
Admixture System," and filed by Eliuk et al. on Mar. 27, 2006 shows
a syringe manipulator device.
In some implementations, alternative types of sensor probes, such
as a beam sensor or a laser range sensor, are affixed to the end of
the robot. A sensor is mounted on a subsystem or interface point
and the robot includes gripper fingers. The sensor locates the
robot gripper fingers and determines the interface of the robot to
the subsystem or interface point that includes the sensor. A touch
probe sensor may be permanently mounted to an APAS subsystem frame
of interest to perform the teaching in order to check the integrity
of the robot gripper fingers.
In some implementations, teach tools (teach sensors) include
multiple tools in a set where a tool in the set can be autonomously
selectable by the robot. The teach tools in a set are located in a
fixed or rotating station. The robot that includes gripper fingers
selects a tool in the set by grabbing the tool from the fixed or
rotating station. Additionally, the teach tools (teach sensors) can
include multiple tools in one or more tool sets where a tool set is
autonomously selectable by the robot. The robot grabs a set of
tools selected by a rotating or other indexer that is autonomously
controlled and utilized by the robot. The robot grabbing a set of
tools at one time may speed tool switching.
In some implementations, robot interfaces are taught without the
use of a sensor or teach tool. The robot contacts or pushes against
a subsystem with its flange or gripper fingers. The APAS controller
detects the contact of the robot with the subsystem by monitoring
the control loop deviation in the robot arm or by monitoring the
increase in selective joint currents in the robot arm. For example,
an APAS subsystem includes a sensor (e.g., a strain gauge, a beam)
to detect the contact or push of the robot against it. In this
case, the robot or gripper fingers may not include a sensor. In
another example, the APAS uses the robot as a signal-circuit
ground. The APAS subsystem can electrically detect the metallic
contact of the robot to determine one or more teach points.
In some implementations, the APAS uses vision techniques for
autonomous teaching of the robot. For example, a camera mounted on
the robot locates subsystem features. The APAS controller uses the
location of the subsystem features to teach points or to refine
teach points. In another example, a camera on a subsystem is used
to teach robot or other interface positions. The robot gripper
fingers include fiducial marks that enable the gripper fingers to
be located in the field of view of a camera included a syringe
capper station. The APAS controller uses this information to refine
the robot position in the field of view of the camera to increase
the accuracy of syringe capping. FIGS. 57-62 of previously
incorporated by reference U.S. patent application Ser. No.
11/389,995, entitled "Automated Pharmacy Admixture System," and
filed by Eliuk et al. on Mar. 27, 2006 show a syringe capping
station.
A plurality of different controllers can control the teaching
protocol used by the APAS. The different controllers can include,
but are not limited to, a robot controller, an APAS controller or
an external computer interfacing to a database and controller in an
APAS where the taught points are autonomously transferred to a
database in the APAS.
The benefits of autonomous teaching can include, but are not
limited to, reduced teaching time resulting in cost savings;
reduced operation cell access requirements; reduced operator skill
level and fatigue; improved accuracy and repeatability; and more
frequent updates leading to longer term stability and
reliability.
FIG. 46 is an example swimlane diagram showing a system 4600 for
using an APAS. In the following example, a first user, a doctor,
adds a first series of drug orders to an APAS, and a second series
of orders, for use by the same doctor, are automatically generated
and loaded to the APAS by a hospital's cancer treatment server. A
second user prepares the APAS and commands the cell to process both
series of drug orders.
During the evening, the hospital's cancer treatment server
generates a list of known expected drugs for administration by the
doctor to patients with appointments for the doctor that day. The
server saves the list of known expected drugs as a first series of
drug orders to an FTP server monitored 4604 by the APAS' network
interface 4602. Due to a late change in scheduling, the doctor
discovers additional drugs will be needed for a new patient. The
doctor enters these new orders 4608 as a second series of drug
orders via a remote user station's user interface 4606 associated
with the APAS.
The APAS controller 4610 creates two queues 4612 of drug orders. A
first queue contains the drug orders of the first series. The
second queue contains the drug orders of the second series. The
second queue is given a priority of "Stat" by the first user so
that they will be processed first, and the drugs will be available
first. The sequence number of drug orders within each queue is
managed and sorted 4614 by the APAS controller 4610 in order to use
hospital inventory as efficiently as possible.
A phantom queue is generated 4616 by the APAS controller 4610 and
considered by the APAS, along with the first and second queue, for
the purposes of determining inventory requirements. In this
example, another doctor has required a third series of drug orders
every day for the last week. The phantom queue is filled with the
third series of drug orders.
After the three queues are prepared, a third user, an APAS
operations technician, logs into the APAS. The third user is
presented, via the user interface 4606, with the three queues, a
list of inventory required to process the three queues, and a
schematic diagram of APAS carousels and the inventory that is to be
placed in each carousel position 4618. The third user reviews the
orders, and loads the inventory 4622 into the carousel 4620 as
described in the schematic.
The third user then commands the APAS to begin processing the real
orders. The APAS cell 4624 begins processing the second queue 4626,
which has the "Stat" priority, according to the sequence number of
each drug order. During the processing of the second queue, the
APAS can create an intermediary bag. To create the intermediary
bag, a vial, IV bag, and syringe are retrieved by the APAS. The
bag, having previously been drawn down to 100 ml, was located in a
temporary parking area and retrieved using an end effector
associated with the IV bag type. The syringe and vial, having been
loaded by the second user, are located in the inventory
carousel.
The syringe is decapped by the APAS. The IV bag is drawn down to 90
ml. The syringe draws 10 ml of fluid from the vial and inserts the
fluid into the bag. To access the fluid in the vial, the syringe
punctures the bung of the vial at or in close proximity to a
previous puncture hole, if there is one. The syringe can be moved
within the APAS in a path so as not to pass over any other
equipment to substantially minimize the chance that any drops might
fall on other surfaces in the APAS. A label identifying the drugs
associated with the order is printed and applied to the syringe on
a printer platen. The vial is weighed by the APAS and found to be
lighter than expected. This weight discrepancy triggers a weight
error by the APAS controller 4628.
To recover from the weight error, any finished and/or salvageable
drugs are output or returned to inventory in the APAS. The syringe
is recapped and disposed of 4632 in an APAS waste bin 4630 for
holding syringes. The IV bag is disposed of 4632 in an APAS waste
bin 4630 for holding IV bags. The vial is labeled as containing
anomalous contents and output 4636 through an output chute 4634 as
a reject. To release the vial into the output chute, gripper
fingers holding the vial can open one mm and move down the vertical
axis of the vial five mm to unstuck the vial label from the gripper
fingers. The third user may determine if the vial should be
disposed of or reclaimed for future use. Upon confirmation from the
output chute that the vial has been removed, the drug order being
processed when the weight error was detected is enqueued 4638 back
into the second queue by the APAS controller 4610. The second queue
is resorted, and the drug order moves to the head of the queue
since it has the highest remaining sequence order. The APAS cell
4624 continues processing the second queue 4640 and outputs the
resulting drugs.
A number of embodiments have been described. Nevertheless, it will
be understood that various modifications may be made without
departing from the spirit and scope. For example, advantageous
results may be achieved if the steps of the disclosed techniques
were performed in a different sequence, if components in the
disclosed systems were combined in a different manner, or if the
components were replaced or supplemented by other components. The
functions and processes (including algorithms) may be performed in
hardware, software, or a combination thereof. Accordingly, other
embodiments are contemplated.
* * * * *
References